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Microbial variability - intra- and inter-subject differences.

The distribution of Phyla based on sample type (all samples).

A complete list of elements detected in Aquamin® (Mineral composition).

Metabolomic (Bile acids and SCFA) profile of colon biopsies.

Demographic characteristics of the participant population.

PDF file - 95K, Flow Diagram of a Trial of Ginger Supplementation Over Four Weeks on Markers of Apoptosis, Proliferation and Differentiation in the Normal-Appearing Colorectal Mucosa of Individuals at Increased Risk of CRC

PDF file - 63K, Cell Cycle Biomarkers of Risk

PDF file - 65K, Adverse Events (AE)Reported by Participant

Supplemental Tables/Figures legends

The distribution of Genera based on sample type (all samples).

The evaluation of eicosanoid metabolites in colon tissue.

Aquamin is a calcium-, magnesium-, and multiple trace element–rich natural product with colon polyp prevention efficacy based on preclinical studies. The goal of this study was to determine the effects of Aquamin on colonic microbial community and attendant metabolomic profile. Thirty healthy human participants were enrolled in a 90-day trial in which Aquamin (delivering 800 mg of calcium per day) was compared with calcium alone or placebo. Before and after the intervention, colonic biopsies and stool specimens were obtained. All 30 participants completed the study without serious adverse event or change in liver and renal function markers. Compared with pretreatment values, intervention with Aquamin led to a reduction in total bacterial DNA (P = 0.0001) and a shift in the microbial community measured by thetaYC (θYC; P = 0.0087). Treatment with calcium also produced a decline in total bacteria, but smaller than seen with Aquamin, whereas no reduction was observed with placebo in the colon. In parallel with microbial changes, a reduction in total bile acid levels (P = 0.0375) and a slight increase in the level of the short-chain fatty acid (SCFA) acetate in stool specimens (P < 0.0001) from Aquamin-treated participants were noted. No change in bile acids or SCFAs was observed with calcium or placebo. We conclude that Aquamin is safe and tolerable in healthy human participants and may produce beneficial alterations in the colonic microbial community and the attendant metabolomic profile. Because the number of participants was small, the findings should be considered preliminary.

OBJECTIVE Medication access and adherence are important determinants of health outcomes. We investigated factors associated with access and cost-related nonadherence to prescriptions in a population-based cohort of systemic lupus erythematosus (SLE) patients and controls. METHODS Detailed sociodemographic and prescription data were collected by structured interview in 2014-2015 from participants in the Michigan Lupus Epidemiology and Surveillance (MILES) cohort. We compared access between cases and frequency-matched controls and examined associated factors in separate multivariable logistic regression models. RESULTS A total of 654 participants (462 SLE patients, 192 controls) completed the baseline visit; 584 (89%) were female, 285 (44%) were Black, and the mean age was 53 years. SLE patients and controls reported similar frequencies of being unable to access prescribed medications (12.1% versus 9.4%, respectively; P was not significant). SLE patients were twice as likely as controls to report cost-related prescription nonadherence in the preceding 12 months to save money (21.7% versus 10.4%; P = 0.001) but were also more likely to ask their doctor for lower cost alternatives (23.8% versus 15.6%; P = 0.02). Disparities were found in association with income, race, and health insurance status, but the main findings persisted after adjusting for these and other variables in multivariable models. CONCLUSION SLE patients were more likely than controls from the general population to report cost-related prescription nonadherence, including skipping doses, taking less medicine, and delaying filling prescriptions; yet

A growing number of cancer patients use complementary and alternative therapies during and after conventional cancer treatment. Patients are often reluctant to discuss these therapies with their oncologist, and oncologists may have limited knowledge and confidence on how to advise patients on the appropriate use. Integrative oncology is a patient-centered, evidence-informed field that utilizes mind–body practices, lifestyle modifications and/or natural products interwoven with conventional cancer treatment. It prioritizes safety and best available evidence to offer appropriate interventions alongside conventional care. There are few opportunities for oncologists to learn about integrative oncology. In this commentary, we highlight the Integrative Oncology Scholars (IOS) program as a means to increase competency in this growing field. We provide an overview of several integrative oncology modalities that are taught through this program, including lifestyle modifications, physical activity, and mind–body interventions. We conclude that as more evidence is generated in this field, it will be essential that oncology healthcare providers are aware of the prevalent use of these modalities by their patients and cancer centers include Integrative Oncology trained physicians and other healthcare professionals in their team to discuss and recommend evidence-based integrative oncology therapies alongside conventional cancer treatments to their patients.

We evaluated associations of the Empirical Dietary Index for Hyperinsulinemia (EDIH), Empirical Dietary Inflammatory Pattern (EDIP) and Healthy Eating Index (HEI2015) and their metabolomics profiles with the risk of total and site-specific cancers. We used baseline food frequency questionnaires to calculate dietary scores among 112,468 postmenopausal women in the Women’s Health Initiative. We used multivariable-adjusted Cox regression to estimate hazard ratios (HR) and 95% confidence intervals for cancer risk estimation. Metabolomic profile scores were derived using elastic-net regression with leave-one-out cross validation. In over 17.8 years, 18,768 incident invasive cancers were adjudicated. Higher EDIH and EDIP scores were associated with greater total cancer risk, and higher HEI-2015 with lower risk: HRQ5vsQ1(95% CI): EDIH, 1.10 (1.04–1.15); EDIP, 1.08 (1.02–1.15); HEI-2015, 0.93 (0.89–0.98). The multivariable-adjusted incidence rate difference(Q5vsQ1) for total cancer was: +52 (EDIH), +41 (EDIP) and −49 (HEI-2015) per 100,000 person years. All three indices were associated with colorectal cancer, and EDIH and EDIP with endometrial and breast cancer risk. EDIH was further associated with luminal-B, ER-negative and triple negative breast cancer subtypes. Dietary patterns contributing to hyperinsulinemia and inflammation were associated with greater cancer risk, and higher overall dietary quality, with lower risk. The findings warrant the testing of these dietary patterns in clinical trials for cancer prevention among postmenopausal women.

Integrative oncology is a burgeoning field and typically provided by a multiprofessional team. To ensure cancer patients receive effective, appropriate, and safe care, health professionals providing integrative cancer care should have a certain set of competencies. The aim of this project was to define core competencies for different health professions involved in integrative oncology. The project consisted of two phases. A systematic literature review on published competencies was performed, and the results informed an international and interprofessional consensus procedure. The second phase consisted of three rounds of consensus procedure and included 28 experts representing 7 different professions (medical doctors, psychologists, nurses, naturopathic doctors, traditional Chinese medicine practitioners, yoga practitioners, patient navigators) as well as patient advocates, public health experts, and members of the Society for Integrative Oncology. A total of 40 integrative medicine competencies were identified in the literature review. These were further complemented by 18 core oncology competencies. The final round of the consensus procedure yielded 37 core competencies in the following categories: knowledge (n = 11), skills (n = 17), and abilities (n = 9). There was an agreement that these competencies are relevant for all participating professions. The integrative oncology core competencies combine both fundamental oncology knowledge and integrative medicine competencies that are necessary to provide effective and safe integrative oncology care for cancer patients. They can be used as a starting point for developing profession-specific learning objectives and to establish integrative oncology education and training programs to meet the needs of cancer patients and health professionals.

Rheumatic diseases are a leading cause of chronic, noncancer pain. Systemic lupus erythematosus (SLE) is a chronic autoimmune rheumatic disease characterized by periodic flares that can result in irreversible target organ damage, including end-stage renal disease. Both intermittent and chronic musculoskeletal pain, as well as fibromyalgia (considered a centralized pain disorder due to dysregulation of pain processing in the central nervous system), are common in SLE. Opioids are generally not indicated for long-term management of musculoskeletal pain or centralized pain (fibromyalgia) because of lack of efficacy, safety issues ranging from adverse medical effects to overdose, and risk for addiction (1,2). In this study of 462 patients with SLE from the population-based Michigan Lupus Epidemiology and Surveillance (MILES) Cohort and 192 frequency-matched persons without SLE, nearly one third (31%) of SLE patients were using prescription opioids during the study period (2014-2015), compared with 8% of persons without SLE (p0.001). Among the SLE patients using opioids, 97 (68%) were using them for1 year, and 31 (22%) were concomitantly on two or more opioid medications. Among SLE patients, those using the emergency department (ED) were approximately twice as likely to use prescription opioids (odds ratio [OR] = 2.1; 95% confidence interval [CI] = 1.3-3.6; p = 0.004). In SLE, the combined contributions of underlying disease and adverse effects of immunosuppressive and glucocorticoid therapies already put patients at higher risk for some known adverse effects attributed to long-term opioid use. Addressing the widespread and long-term use of opioid therapy in SLE will require strategies aimed at preventing opioid initiation, tapering and discontinuation of opioids among patients who are not achieving treatment goals of reduced pain and increased function, and consideration of nonopioid pain management strategies.

Cancer-related fatigue (CRF) is a common symptom for which cancer patients often use integrative and integrative therapies; however, evidence supporting these therapies is limited. The aim of this review is to provide evidence-based recommendations for integrative interventions during and after cancer treatment for CRF. These recommendations are based on a systematic literature review from 1990 through 2019. Cognitive behavior therapy plus hypnosis and American ginseng can be considered during active treatment, and acupressure, mindfulness-based cognitive therapy, and qigong/tai chi easy can be considered during post-treatment. Coenzyme Q10 and l-carnitine are not recommended during active-treatment. All other integrative therapies for CRF had insufficient evidence to make a recommendation. While there is increasing evidence for integrative therapies for CRF, because of lack of rigorous trials and replication, no therapies could be definitively recommended. Further rigorously designed integrative therapy research is needed and should consider implementation and dissemination.

Objective Chronic low back pain (CLBP) is associated with fatigue, pain, poor sleep, and disability. Acupressure is a low-risk treatment option used to manage symptoms in other groups, but its efficacy, particularly on fatigue and sleep, is unknown in CLBP. This study examined preliminary effects of two types of self-administered acupressure (relaxing and stimulating) on fatigue, pain, sleep, and reported disability. Methods A randomized pilot trial was conducted (N = 67) in which participants were randomized into six weeks of relaxing acupressure, stimulating acupressure, or usual care. Fatigue was measured by the Brief Fatigue Inventory, pain was measured by the Brief Pain Inventory, sleep was measured by the Pittsburgh Sleep Quality Index, and reported disability was measured by the Roland Morris Scale. Results Baseline characteristics were similar across groups. An intent-to-treat analysis using general linear models showed positive improvement in pain in acupressure groups compared with usual care. Pain was reduced by 35–36% in the acupressure groups. Improvement in fatigue was also found in stimulating acupressure compared with usual care. Adverse events were minimal and related to application of too much pressure. Discussion Although this was a small study, acupressure demonstrated promising preliminary support of efficacy for pain and fatigue reduction in this population.

Background Persistent cancer-related fatigue is one of the most common and burdensome symptoms experienced by ovarian cancer survivors. Despite the high burden of fatigue in ovarian cancer survivors, there are few available treatments. Previous research has shown self-acupressure to be a safe method for improving persistent fatigue, sleep, and quality of life among fatigued breast cancer survivors, yet there are no studies examining self-acupressure for fatigue in ovarian cancer survivors. Methods A three group parallel, randomized controlled trial will be conducted to evaluate the efficacy of self-acupressure taught and delivered via a patient-designed, custom-built mobile app ("MeTime") and accompanying hand-held device ("AcuWand") to help guide correct pressure application. A sample of 165 ovarian cancer survivors, who have completed primary cancer treatment will be recruited from tumor registries in Michigan and Los Angeles. Participants will be mailed a tablet preloaded with the app and a device, and all visits will be conducted remotely. Participants will be randomized to 6-weeks of daily self-acupressure via the app and device, or a sham app and device, or no care group. Self-report measures will be completed at baseline, 6-weeks (post-intervention), 3-, and 6-months. Primary outcome is the Brief Fatigue Inventory; secondary outcomes are sleep, quality of life, and symptoms commonly associated with persistent fatigue. Discussion An app based self-acupressure treatment may be an easily-accessible and inexpensive treatment to reduce fatigue in ovarian cancer survivors. The results of the study will provide information on the possible benefits of app-based self-acupressure for fatigue in ovarian cancer survivors. Trial registration: This study is registered at ClinicalTrials.gov Identifier: NCT03763838, date registered on December 4, 2018.

The overall goal of this study was to determine whether Aquamin®, a calcium-, magnesium-, trace element-rich, red algae-derived natural product, would alter the expression of proteins involved in growth-regulation and differentiation in colon. Thirty healthy human subjects (at risk for colorectal cancer) were enrolled in a three-arm, 90-day interventional trial. Aquamin® was compared to calcium alone and placebo. Before and after the interventional period, colonic biopsies were obtained. Biopsies were evaluated by immunohistology for expression of Ki67 (proliferation marker) and for CK20 and p21 (differentiation markers). Tandem mass tag-mass spectrometry-based detection was used to assess levels of multiple proteins. As compared to placebo or calcium, Aquamin® reduced the level of Ki67 expression and slightly increased CK20 expression. Increased p21 expression was observed with both calcium and Aquamin®. In proteomic screen, Aquamin® treatment resulted in many more proteins being upregulated (including pro-apoptotic, cytokeratins, cell–cell adhesion molecules, and components of the basement membrane) or downregulated (proliferation and nucleic acid metabolism) than placebo. Calcium alone also altered the expression of many of the same proteins but not to the same extent as Aquamin®. We conclude that daily Aquamin® ingestion alters protein expression profile in the colon that could be beneficial to colonic health.

The overall goal of this study was to determine if Aquamin®, a calcium- and magnesium-rich natural product, would alter the expression of proteins involved in growth-regulation, differentiation and barrier formation in the colon. Thirty healthy human subjects were enrolled in a three-arm, 90-day interventional trial in which Aquamin®(provided daily to deliver 800-mg of calcium per day) was compared to calcium alone and placebo. Before and after the 90-day interventional period, colonic biopsies were obtained. Biopsies were evaluated by immunohistology for expression of Ki67 (a proliferation marker) and for CK20 and p21 (differentiation markers). Tandem mass tag-mass spectrometry-based detection was used to assess levels of multiple proteins. As compared to placebo or calcium, Aquamin®reduced the level of Ki67 expression (20%). Neither intervention altered CK20 expression, while a trend toward increased p21 was observed with calcium and Aquamin®(117% and 99% respectively). In the proteomic screen, Aquamin®treatment resulted in many more proteins being upregulated or downregulated (1.5 fold-change with ≤2% false-discovery rate) than placebo. Included among the upregulated proteins were cytokeratins, cell-cell adhesion molecules and components of the basement membrane. Many of the downregulated proteins were those involved in proliferation and nucleic acid metabolism. Calcium alone also altered the expression of many of the same proteins but not to the same extent as Aquamin®. We conclude that daily Aquamin®ingestion alters protein expression profile in the colon that could be beneficial to colonic health. These data warrant additional studies with a larger sample size to validate these findings.Prevention RelevanceA multi-mineral approach reduced proliferation and induced differentiation inex vivosettings and has been shown to decrease colon polyp incidence in mouse (polyp-prevention) studies. The findings from a 90-day trial in human subjects (presented here) demonstrated improved biomarker-modulation efficacy, warranting to conduct the polyp-prevention trial in at-risk human subjects.

Shared decision making is an important aspect of high-quality health care and incorporates understanding patients’ beliefs around how medication works, the potential side effects, and expected benefits. Gaining this understanding helps to guide the decision of which medications most closely align

Context Yoga improves quality of life in elders ≥65 years, but studies among elders with chronic pain are limited. Objective Conduct a feasibility study of gentle yoga among elders in assisted and independent living. Design Single arm pre/post clinical trial. Subjects Adults (≥65 years of age) with self-identified chronic pain (≥3 on a 10-point scale, lasting for ≥3 months) and no current yoga practice. Intervention Ten weekly 60-min gentle yoga classes tailored to elderly adults. Outcome measures At baseline, weeks 5, 10 (end of intervention), and 20 (follow-up), we collected data on feasibility (adherence, retention, safety), pain, anxiety, depression, fatigue, sleep disturbance, and physical function. Results Twenty-six participants enrolled (88% women, 77% white, 58% in assisted living) with average age of 86.6 ± 4.4 (Mean, STD). Twenty participants completed the intervention, with 90% adhering (completing ≥6 classes). Nine participants (45% of completers) experienced adverse events, which were non-serious and related to transient musculoskeletal pain. No adverse events resulted in study withdrawal. Participants reported being somewhat likely to recommend yoga to a friend, and quite a bit likely to do yoga again. At the end of the intervention, four of twenty participants reported practicing yoga outside of class. Anxiety significantly decreased from 5.80 (SE=0.90) to 4.44 (SE=0.74) (p = 0.014), but there were no changes in other measures. Conclusions Our pilot 10-week yoga study was generally safe for and suitable to assisted and independent living elderly adults. Future studies are needed to examine other effects of yoga in assisted/independent living adults with chronic pain.

Clinical laboratories are under pressure to increase value by improving test utilization. The clinical utility of reverse triiodothyronine (rT3) is controversial. A study was conducted to identify order patterns that might suggest inappropriate utilization of rT3.All orders for thyroid tests placed over a period of one year at a national reference laboratory were reviewed. Order patterns by client (hospital) and by provider were analyzed. A Pareto analysis was conducted to determine the percentage of orders placed as a function of the percentage of providers. A systematic review of the indexed literature and an informal review of the web were conducted to identify indications for rT3 testing.There were 402,386 orders for 447,664 thyroid tests, including 91,767 orders for rT3. These orders were placed by 60,733 providers located at 1139 different organizations. Only 20% of providers who ordered thyroid tests placed an order for rT3. Of those who placed an order for rT3, 95% placed two orders or fewer for rT3. One hundred providers (0.1% of the 60,733 providers who placed orders for thyroid tests) accounted for 29.5% of the orders for rT3. Of the 100 providers, 60 with the highest order volumes for rT3 were classified as practitioners of functional medicine. A systematic review of Medline found little evidence to support the high volumes of orders for rT3. A survey of Web sites for functional medicine suggests that rT3 is useful for the diagnosis of rT3 dominance and can be used to direct triiodothyronine replacement therapy.There is wide practice variation in rT3 testing. A high proportion of tests are ordered by a relatively small proportion of providers. There is little evidence to support high volumes of rT3 testing placed by some practitioners.

Answer questions and earn CME/CNE Patients with breast cancer commonly use complementary and integrative therapies as supportive care during cancer treatment and to manage treatment-related side effects. However, evidence supporting the use of such therapies in the oncology setting is limited. This report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance. Clinical practice guidelines are based on a systematic literature review from 1990 through 2015. Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders. Meditation and yoga are recommended to improve quality of life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting. Acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy due to a possibility of harm. No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related side effects. In summary, there is a growing body of evidence supporting the use of integrative therapies, especially mind-body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided. CA Cancer J Clin 2017;67:194-232. © 2017 American Cancer Society.

Fatigue is a prevalent and burdensome effect of breast cancer. Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue.Pilot, randomized, trial conducted between January 2014 and April 2015, to investigate if a 3-month diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods, named the fatigue reduction diet (FRD), improved fatigue and sleep compared to an attention control, named the general health curriculum (GHC). 30 stage 0 to III breast cancer survivors, who had completed cancer treatments, were randomized: 15 receiving the FRD and 15 the GHC. Primary outcome was change in fatigue, as measured by the brief fatigue Inventory, from baseline to 3 months analyzed using linear mixed models. Secondary analyses were changes in sleep quality, serum carotenoids, and fatty acids.From baseline to 3-month fatigue improved by 44 ± 39% in FRD compared to 8 ± 34% in GHC (p = 0.01); sleep quality improved by 2.5 ± 3.3 points in FRD, and diminished by 0.9 ± 2.3 in GHC (p = 0.03); serum total carotenoids (p 0.01), β-cryptoxanthin (p = 0.02), lutein (p = 0.05), zeaxanthin (p = 0.01), lycopene (p = 0.05), omega-3 fatty acids (p 0.01), and ratio of omega-3:omega-6 fatty acids (p = 0.02) were significantly increased, and percent saturated fatty acids were decreased (p = 0.04) in FRD; γ-tocopherol was significantly increased in GHC (p = 0.03), and there was a significant visit by group difference for α-carotene between the study groups (p = 0.05).The FRD intervention improved fatigue and sleep in breast cancer survivors compared to the GHC. FRD diet could provide a non-toxic treatment strategy for persistent fatigue.

Aquamin is a calcium-, magnesium-, and multiple trace element–rich natural product with colon polyp prevention efficacy based on preclinical studies. The goal of this study was to determine the effects of Aquamin on colonic microbial community and attendant metabolomic profile. Thirty healthy human participants were enrolled in a 90-day trial in which Aquamin (delivering 800 mg of calcium per day) was compared with calcium alone or placebo. Before and after the intervention, colonic biopsies and stool specimens were obtained. All 30 participants completed the study without serious adverse event or change in liver and renal function markers. Compared with pretreatment values, intervention with Aquamin led to a reduction in total bacterial DNA (P = 0.0001) and a shift in the microbial community measured by thetaYC (θYC; P = 0.0087). Treatment with calcium also produced a decline in total bacteria, but smaller than seen with Aquamin, whereas no reduction was observed with placebo in the colon. In parallel with microbial changes, a reduction in total bile acid levels (P = 0.0375) and a slight increase in the level of the short-chain fatty acid (SCFA) acetate in stool specimens (P < 0.0001) from Aquamin-treated participants were noted. No change in bile acids or SCFAs was observed with calcium or placebo. We conclude that Aquamin is safe and tolerable in healthy human participants and may produce beneficial alterations in the colonic microbial community and the attendant metabolomic profile. Because the number of participants was small, the findings should be considered preliminary.

BackgroundCancer survivors with fatigue often experience depressive symptoms, anxiety, and pain. Previously, we reported that self-acupressure improved fatigue; however, its impact on other co-occurring symptoms and their involvement in treatment action has not been explored.MethodsChanges in depressive symptoms, anxiety, and pain were examined prior to and following two formulas of self-acupressure and usual care using linear mixed models in 288 women from a previously reported clinical trial. Participants were categorized by random assignment into one of three groups: 1) relaxing acupressure, 2) stimulating acupressure, or 3) usual care. Moderators investigated were body mass index, age, depressive symptoms, anxiety, sleep and pain, and mediators were change in these symptoms.ResultsFollowing treatment, depressive symptoms improved statistically significantly for the relaxing acupressure group (41.5%) compared with stimulating acupressure (25%) and usual care (7.7%). Both acupressure groups were associated with greater improvements in anxiety than usual care, but only relaxing acupressure was associated with greater reductions in pain severity, and only stimulating acupressure was associated with greater reductions in pain interference. There were no statistically significant moderators of sleep quality, anxiety, or depressive symptoms. Fatigue statistically significantly moderated pain, and age statistically significantly modified fatigue. Changes in depressive symptoms and sleep quality statistically significantly mediated the relationship between relaxing acupressure and usual care on fatigue; however, the effect was small.ConclusionsAcupressure was associated with greater improvements than usual care in anxiety, pain, and symptoms of depression in breast cancer survivors with troublesome fatigue. These findings warrant further evaluation in suitably controlled randomized trials.

Complementary and integrative treatments, such as massage, acupuncture, and yoga, are used by increasing numbers of cancer patients to manage symptoms and improve their quality of life. In addition, such treatments may have other important and currently overlooked benefits by reducing tissue stiffness and improving mobility. Recent advances in cancer biology are underscoring the importance of connective tissue in the local tumor environment. Inflammation and fibrosis are well-recognized contributors to cancer, and connective tissue stiffness is emerging as a driving factor in tumor growth. Physical-based therapies have been shown to reduce connective tissue inflammation and fibrosis and thus may have direct beneficial effects on cancer spreading and metastasis. Meanwhile, there is currently little knowledge on potential risks of applying mechanical forces in the vicinity of tumors. Thus, both basic and clinical research are needed to understand the full impact of integrative oncology on cancer biology as well as whole person health. Cancer Res; 76(21); 6159–62. ©2016 AACR.

Adults with chronic spinal pain had significantly poorer quality diets. Individuals with the highest diet quality were 24% less likely to report chronic spinal pain., Introduction: Chronic spinal pain is disabling and has high personal and societal costs. Risk factors include behavioral factors; however, little is known about the role of diet quality and its association with spinal pain. Higher diet quality and consumption of macronutrients that drive higher diet quality were hypothesized to be associated with lower odds of having spinal pain. Methods: An analysis of a population-based data set (NHANES cycle 2009–2010) was conducted. Diet quality was calculated using the Healthy Eating Index 2015 (score 0–100). To examine odds of pain related to dietary intake, generalized linear regressions were used adjusting for relevant covariates. Results: Of 4123 participants (mean age 43.5 ± 0.44 [SD], 2167 [52.6%] female), 800 (19.4%) reported chronic spinal pain. People with chronic spinal pain consumed similar amounts of calories to those with no spinal pain (2137 ± 44.5 vs 2159.9 ± 27.7), but had significantly poorer diet quality compared to people without spinal pain (51.97 ± 0.65 vs 54.31 ± 0.39, P = 0.007). From multivariate analyses, individuals with diet quality in the highest tertile on Healthy Eating Index-2015 were 24% less likely to report chronic spinal pain relative to those in the lowest tertile. Higher fruit, whole grain, and dairy intake were associated with 20% to 26% lower likelihood (all P for trend

Objective To examine associations between dietary intake of omega-3 (n-3; generally antiinflammatory) and omega-6 (n-6; generally proinflammatory) fatty acids and patient-reported outcomes in systemic lupus erythematosus (SLE). Methods This study was based on the population-based Michigan Lupus Epidemiology and Surveillance cohort. Estimates of n-3 and n-6 intake were derived from Diet History Questionnaire II items (past year with portion size version). Patient-reported outcomes included self-reported lupus activity (Systemic Lupus Activity Questionnaire [SLAQ]). Multivariable regression, adjusted for age, sex, race, and body mass index, was used to assess associations between absolute intake of n-3 and n-6, as well as the n-6:n-3 ratio, and patient-reported outcomes. Results Among 456 SLE cases, 425 (93.2%) were female, 207 (45.4%) were African American, and the mean ± SD age was 52.9 ± 12.3 years. Controlling for potential confounders, the average SLAQ score was significantly higher by 0.3 points (95% confidence interval [95% CI] 0.1, 0.6; P = 0.013) with each unit increase of the n-6:n-3 ratio. Both lupus activity and Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scores were lower with each 1-gram/1,000 kcal increase of n-3 fatty acids (SLAQ regression coefficient β = -0.8 [95% CI -1.6, 0.0]; P = 0.055; PROMIS sleep β = -1.1 [95% CI -2.0, -0.2]; P = 0.017). Higher n-3 intakes were nonsignificantly associated with lower levels of depressive symptoms and comorbid fibromyalgia, and with higher quality of life, whereas results for the n6:n3 ratio trended in the opposite direction. Conclusion This population-based study suggests that higher dietary intake of n-3 fatty acids and lower n-6:n-3 ratios are favorably associated with patient-reported outcomes in SLE, particularly self-reported lupus activity and sleep quality.

Objectives: Oncology providers are often confronted by patients who use complementary or alternative therapies, but have limited knowledge or confidence on how to advise patients on appropriate use. Despite this, there are few opportunities for oncology providers to learn about complementary or alternative therapies, while at the same time there is a high demand for integrative oncology (IO) training. To address a gap in IO educational opportunities, and particularly for nonphysicians, we created the Integrative Oncology Scholars (IOS) Program. The program's goal is to train 100 IO leaders and facilitate partnerships between them and complementary practitioners. Design: Four iterations of a year-long National Cancer Institute-funded educational program that combines in-person team-based learning and eLearning to teach the evidence, application, and philosophy supporting IO. Settings: In-person sessions take place at the University of Michigan, and eLearning is implemented using a Canvas website (Instructure, Inc., Salt Lake City, UT). Subjects: Nurses, social workers, physician assistants, psychologists, physicians, pharmacists, and physical/occupational therapists with active oncology practices. Educational intervention: Four cohorts of 25 oncology providers per year will learn the evidence base for complementary and alternative approaches to a wide number of oncology topics, including symptom control, dietary supplements commonly used by cancer patients, diet, and the utility of specific integrative approaches for common oncology side-effects such as fatigue. Outcome measures: A mixed methods approach will be used to evaluate overall IOS Program progress and individual scholar's impact on IO research, education, and clinical endeavors. Results: The first cohort of 25 IOS has been recruited and their education will begin in Summer 2018. Scholars come from 13 states and represent 23 different healthcare systems. Conclusions: The IOS Program has the potential to increase the number of trained IO providers, educators, and researchers in the United States.

Diet is the single most significant risk factor for disability and premature death. Patients and physicians often have difficulty staying abreast of diet trends, many of which focus primarily on weight loss rather than nutrition and health. Recommending an eating style can help patients make positive change. Dietary patterns that support health include the Mediterranean diet, the Dietary Approaches to Stop Hypertension diet, the 2015 Dietary Guidelines for Americans, and the Healthy Eating Plate. These approaches have benefits that include prevention of cardiovascular disease, cancer, type 2 diabetes mellitus, and obesity. These dietary patterns are supported by strong evidence that promotes a primary focus on unprocessed foods, fruits and vegetables, plant-based fats and proteins, legumes, whole grains, and nuts. Added sugars should be limited to less than 5% to 10% of daily caloric intake. Vegetables (not including potatoes) and fruits should make up one-half of each meal. Carbohydrate sources should primarily include beans/legumes, whole grains, fruits, and vegetables. An emphasis on monounsaturated fats, such as olive oil, avocados, and nuts, and omega-3 fatty acids, such as flax, cold-water fish, and nuts, helps prevent cardiovascular disease, type 2 diabetes, and cognitive decline. A focus on foods rather than macronutrients can assist patients in understanding a healthy diet. Addressing barriers to following a healthy diet and utilizing the entire health care team can assist patients in following these guidelines.

Introduction Healthy food incentives matching Supplemental Nutrition Assistance Program (SNAP) benefits spent on fruits and vegetables subsidize increased produce consumption among low-income individuals at risk for food insecurity and diet-related disease. Yet many eligible participants do not use these incentives, in part because of limited awareness. This study examined the acceptability and impact of a primary care–based informational intervention on facilitators and barriers to use of the statewide SNAP incentive program Double Up Food Bucks. Methods Focus groups (n=5) were conducted April–June 2015 among a purposive sample (n=26) of SNAP-enrolled adults from a Michigan health clinic serving low-income patients. All had participated in a waiting room-based informational intervention about Double Up Food Bucks; none had used Double Up Food Bucks before the intervention. Groups were stratified by Double Up Food Bucks use/non-use during the 6-month intervention period. Results were analyzed in 2016–2017 through an iterative content analysis process. Results Participants reported the waiting room intervention was acceptable and a key facilitator of first-time Double Up Food Bucks use. Motivators for Double Up Food Bucks use included (1) eating more healthfully, (2) stretching SNAP benefits, (3) higher-quality produce at markets, and (4) unique market environments. Remaining barriers included (1) lack of transportation, (2) limited market locations/hours, and (3) persistent confusion among a small number of participants regarding incentive use. Conclusions Low-income patients who received an informational intervention about Double Up Food Bucks reported numerous benefits from participation. Yet barriers remained for a subset of patients. Improving geographic accessibility and ease of SNAP incentive redemption may further improve dietary quality and food security among vulnerable populations.

The 11th International Conference of the Society for Integrative Oncology (SIO) brought together more than 300 clinicians, researchers, patients, and advocates to hear and interact with world-leading experts about the latest research in the areas of nutrition, exercise, acupuncture, health services research, meditation, and other integrative disciplines. The conference theme, “Personalized Integrative Oncology: Targeted Approaches for Optimal Outcomes,” highlighted innovations in personalized medicine and ways this growing field will advance the evolution of individualized integrative cancer care to the next level. This year’s conference also featured a clinical track focusing on clinical information for the practicing health care professional. The conference’s rigorous schedule included 3 keynotes, 4 plenary sessions, 2 interdisciplinary tumor boards, 5 workshops, 45 concurrent oral sessions, and 106 posters. In addition to the conference theme, keynote and plenary sessions presented topics on stress and cancer, the importance of sleep for cancer patients, epigenetic mechanisms of lifestyle and natural products, recently published Journal of the National Cancer Institute monograph on integrative oncology, SIO’s clinical practice guidelines for breast cancer survivors, and a joint session of the American Academy of Hospice and Palliative Medicine and SIO about supportive care and symptom management. This highly successful conference helped further the mission of the SIO to advance evidence-based, comprehensive, integrative health care to improve the lives of people affected by cancer.

Background The majority of breast cancer patients use complementary and/or integrative therapies during and beyond cancer treatment to manage symptoms, prevent toxicities, and improve quality of life. Practice guidelines are needed to inform clinicians and patients about safe and effective therapies.

Background: Persistent fatigue is a common and debilitating symptom in breast cancer survivors (BCS), yet treatments remain limited. The purpose of this study was to examine the effect of two types of self-administered acupressure on fatigue versus usual care in BCS. Methods: This was a 10-week randomized trial that enrolled adult female BCS (stage 0-III), who had completed cancer treatments at least 12 months previously and who reported persistent mild-moderate fatigue (≥ 4 on the Brief Fatigue Inventory [BFI]). BCS were randomized equally into relaxation acupressure (RA), stimulating acupressure (SA) or usual care (UC). The primary endpoint was change in BFI from baseline to week 6 when acupressure was stopped and at week 10 to assess carryover effects of acupressure. Secondary analyses were conducted on sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and 14-day sleep diaries; quality of life was assessed with the Long-Term Quality of Life in BCS (LTQL). Intent-to-treat analyses were conducted using linear mixed models. Results: 288 BCS were randomized (98 RA, 94 SA, and 96 UC). 228 BCS completed the 6-week visit and 223 the 10-week visit (71 RA, 69 SA, and 83 UC). There were no significant group differences on baseline sociodemographic, clinical characteristics, BFI, PSQI, sleep diary parameters, or LTQL. At week 6 the mean change in BFI from baseline was significantly lower in the RA and SA arms than UC (RA = -2.57 ± 1.5, SA = -1.98 ± 1.5, and UC = -1.07 ± 1.6; p < 0.001 for both RA and SA vs. UC), but there was no significant difference between acupressure arms (p = 0.29). At week 10 the mean change in BFI from baseline ± SD was maintained and continued to be lower in RA and SA arms than UC (RA = -2.27 ± 1.4, SA = -1.96 ± 1.5, and UC = -0.99 ± 1.5; p < 0.001 for both RA and SA vs. UC), but no significant difference between acupressure arms (p >0.99). At week 6 the mean change in PSQI from baseline mean ± SD for RA = -1.93 ± 3.3 was significantly different from UC = -0.46 ± 3.1 (p = 0.03) but not SA = -1.34 ± 3.2 (p = 0.96). At week10 there was no significant difference on the PSQI between arms (RA vs. UC, p = 0.40; SA vs. UC, p Conclusions: Both acupressure arms significantly reduced fatigue compared to UC, but only RA had a significant effect on improving sleep quality and quality of life in BCS. Improvements in fatigue, sleep, and quality of life continued to persist for 4 weeks after cessation of acupressure. Self-administered RA offers an inexpensive easy to learn method to manage fatigue, sleep quality and overall quality of life in BCS with persistent fatigue. Citation Format: Zick SM, Wyatt GK, Murphy SL, Arnedt JT, Sen A, Harris RE. Acupressure for persistent fatigue in breast cancer survivors. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr PD4-06.

Federal food assistance programs such as the Supplemental Nutrition Assistance Program (SNAP) help address food insecurity, yet many participants still struggle to afford nutritionally adequate foods. The U.S. Department of Agriculture has committed $100 million to the expansion and evaluation of SNAP healthy food incentives, which match SNAP funds spent on produce. However, little is known about who uses SNAP incentives or how often they are used. This study examines patterns and correlates of use of the SNAP incentive Double Up Food Bucks at all eight participating Detroit farmers markets during 2012-2013.SNAP/Double Up Food Bucks transactions from handwritten farmers market logs (n=21,541) were linked with state administrative SNAP enrollment data. Frequency of incentive use and characteristics of Double Up Food Bucks users relative to the overall Detroit SNAP-enrolled population were examined, as were market-level characteristics associated with program use. Negative binomial regression was used to estimate predictors of repeat transactions (analyses conducted 2015-2017).Although demographic characteristics of Double Up Food Bucks users reflected those of the overall Detroit SNAP-enrolled population, Double Up Food Bucks users were poorer and disproportionately female. One third of Double Up Food Bucks users had more than one transaction during the 2-year period. Repeat transactions were directly correlated with identifying as white (incidence rate ratio=2.34, 95% CI=2.11, 2.59, p0.001), and inversely correlated with driving distance from market of first transaction (incidence rate ratio=0.98 per mile, 95% CI=0.98, 0.99, p0.001). Rates of repeat transactions also varied significantly by market.Addressing barriers to initial use and return visits can help maximize the impact and reach of SNAP incentives among Americans at highest risk of diet-related disease.

Objective Complementary and alternative medicine, or integrative medicine, has become increasingly popular among patients with head and neck cancer. Despite its increasing prevalence, many patients feel uncomfortable discussing such therapies with their physicians, and many physicians are unaware and underequipped to evaluate or discuss their use with patients. The aim of this article is to use recent data to outline the decision making inherent to integrative medicine utilization among patients with head and neck cancer, to discuss the ethical implications inherent to balancing integrative and conventional approaches to treatment, and to highlight available resources to enhance head and neck cancer providers' understanding of integrative medicine. Data Sources Randomized controlled trials involving integrative medicine or complementary and alternative medicine treatment for cancer patients. Review Methods Trials were drawn from a systematic PubMed database search categorized into cancer prevention, treatment, and symptom management. Conclusions Integrative medicine is gaining popularity for the management of cancer and is most commonly used for symptom management. A number of randomized controlled trials provide data to support integrative therapies, yet physicians who treat head and neck cancer may be faced with ethical dilemmas and practical barriers surrounding incorporation of integrative medicine. Implications for Practice In the management of head and neck cancer, there is an increasing demand for awareness of, dialogue about, and research evaluating integrative medicine therapies. It is important for otolaryngologists to become aware of integrative therapy options, their risks and benefits, and resources for further information to effectively counsel their patients.

Diet-related disease is disproportionately concentrated in low-income communities where fruit and vegetable consumption is far below guidelines. To address financial barriers, Double Up Food Bucks (DUFB)-a statewide healthy food incentive-matches Supplemental Nutrition Assistance Program (SNAP) funds spent at farmers markets. However, incentive use is limited. This study examined the impact of a brief waiting room-based intervention about DUFB on program utilization and produce consumption.Longitudinal, repeated measures, quasi-experimental trial.SNAP-enrolled adults at a health center in a low-income, racially and ethnically diverse area of Southeast Michigan.Participants received a brief explanation of DUFB, written program materials, a map highlighting market locations and hours, and an initial $10 market voucher. DUFB use and produce consumption were measured through four surveys over 5 months (August 2014-January 2015).Outcome measures included DUFB use and fruit and vegetable consumption (analyses conducted in 2015-2016).A total of 302 eligible adults were identified, and 177 (59%) enrolled. One hundred twenty-seven (72%) completed all surveys. At baseline, 57% of participants reported shopping at a farmers market within the last year; 18% had previously used DUFB. By the end of the DUFB season, participants were significantly more likely to report DUFB use than at baseline (AOR=19.2, 95% CI=10.3, 35.5, p0.001), with 69% of participants reporting use of DUFB at least once, and 34% reporting use of DUFB three or more times. Adjusted fruit and vegetable consumption increased from baseline by 0.65 servings/day (95% CI=0.37, 0.93, p0.001) at 3 months, and remained 0.62 servings/day (95% CI=0.32, 0.92, p0.001) higher than baseline 2 months post-DUFB season.A brief clinic-based intervention was associated with a nearly fourfold increase in uptake of a SNAP incentive program, as well as clinically and statistically significant increases in produce consumption. Results suggested sustained behavior change even once the financial incentive was no longer available. Providing information about healthy food incentives is a low-cost, easily implemented intervention that may increase produce consumption among low-income patients.

Colorectal cancer (CRC) remains a significant cause of mortality. Inhibitors of cyclooxygenase (COX) and thus prostaglandin E2, are promising CRC preventives, but have significant toxicities. Ginger has been shown to inhibit COX, to decrease the incidence and multiplicity of adenomas, and decrease PGE2 concentrations in subjects at normal risk for CRC. This study was conducted to determine the effects of 2.0 g/d of ginger given orally on the levels of PGE2, leukotriene B4 (LTB4), 13-hydroxy-octadecadienoic acids, and 5-, 12-, & 15-hydroxy-eicosatetraenoic acid, in the colonic mucosa of subjects at increased risk for CRC. We randomized 20 subjects to 2.0 g/d ginger or placebo for 28 d. At baseline and Day 28, a flexible sigmoidoscopy was used to obtain colon biopsies. A liquid chromatography mass spectrometry method was used to determine eicosanoid levels in the biopsies, and levels were expressed per amount of protein or free arachidonic acid (AA). There was a significant decrease in AA between baseline and Day 28 (P = 0.05) and significant increase in LTB4 (P = 0.04) when normalized to protein, in subjects treated with ginger versus placebo. No other changes in eicosanoids were observed. There was no difference between the groups in total adverse events (AE; P = 0.06). Ginger lacks the ability to decrease eicosanoid levels in people at increased risk for CRC. Ginger did appear to be both tolerable and safe; and could have chemopreventive effects through other mechanisms. Further investigation should focus on other markers of CRC risk in those at increased CRC risk.

Persistent cancer-related fatigue (PCRF) is one of the most troubling side-effects of breast cancer (BC) treatment. One explanatory model for PCRF is sickness behavior, which is a set of adaptive responses including sleepiness and depressed mood in reaction to an inflammatory trigger. Prior research has investigated differences in inflammatory cytokines between fatigued and non-fatigued BC survivors, but no study has examined differences in brain metabolites. Differences in inflammatory markers, and brain metabolites using proton magnetic resonance spectroscopy were evaluated within 16 fatigued and 13 non-fatigued BC survivors. Fatigued BC survivors had significantly higher ratios of two markers derived from brain metabolites; namely (a) creatine, normalized to total creatine (creatine + phosphocreatine (Cr/tCr)) ratio (P = 0.03) and (b) glutamate + glutamine (Glx) to N-acetyl-aspartate (NAA) ratio (P = 0.01) in the posterior insula compared to non-fatigued breast cancer survivor. Further, serum IL-6 was increased in fatigued women compared to non-fatigued women (P = 0.03), Using receiver operator curves (ROC) we determined that the posterior insula Glx/NAA ratio was the best predictor of fatigue with an overall area under the receiver operating characteristic curve (AUROC) of 79 %, with a sensitivity of 81 % and a specificity of 69 %. However, posterior insula Glx/NAA, Cr/tCr and serum IL-6 were not significantly correlated with one another implying the possibility of independent biological mechanisms for PCRF rather than an interrelated mechanism as represented by the sickness behavior model. This study provides novel preliminary evidence of several distinct neurobiological changes in the posterior insula associated with PCRF in BC survivors. Future, longitudinal studies are needed to explore these distinct biological phenomena where changes through time in peripheral immune markers and brain metabolites are examined to determine if they correlate with changes in fatigue.