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Background: There is considerable interest in the use of cannabinoids for symptom control in palliative care, but there is little high-quality evidence to guide clinical practice. Objectives: Assess the feasibility of using global symptom burden measures to assess response to medicinal cannabis, to determine median tolerated doses of cannabidiol (CBD) and tetrahydrocannabinol (THC), and to document adverse events (AEs). Design: Prospective two-arm open-label pilot trial of escalating doses of CBD and THC oil. Setting/Subjects: Participants had advanced cancer and cancer-related symptoms in a palliative and supportive care service in an Australian cancer center. Measurements: The main outcome measures were the number of participants screened and randomized over the time frame, the number of participants completing days 14 and 28 and providing total symptom distress scores (TSDSs) (measured using the Edmonton Symptom Assessment Scale), and the change from baseline of the TSDS at day 14. Results: Of the 21 participants enrolled (CBD, n  = 16; THC, n  = 5), 18 (86%) completed the primary outcome measure at day 14 and 8 completed at day 28. The median maximum tolerated doses were CBD, 300 mg/day (range 100-600 mg); THC, 10 mg/day (range 5-30 mg). Nine of 21 patients (43%) met the definition of response (≥6 point reduction in TSDS). Drowsiness was the most common AE. Conclusions: Trials of medicinal cannabis in advanced cancer patients undergoing palliative care are feasible. The doses of THC and CBD used in this study were generally well tolerated and the outcome measure of total symptom distress is promising as a measure of overall symptom benefit. Trial registration: ACTRN12618001205224.

Background: Palliative care patients are inherently difficult to recruit to and retain on studies. Even when patients are recruited, it is hard to complete studies with sufficient data. There is a dearth of literature specific to men with castrate resistant prostate cancer (CRPC) and the clinical trials coordinator/research nurse's perspective in improving trial outcomes in palliative care. Objectives To describe the lessons learnt (by the nursing research team) from a prospective cohort study of men with CRPC and the practical implications for future research in this area., Methods: A pilot feasibility cohort study that followed patients with CRPC from referral until death. The participants completed questionnaires while the researcher documented treatments, disease status and symptom burden. The recruitment methods, data quality and results were analysed., Results and Discussion: Several lessons have been learnt with regard to facilitating trial recruitment and design. These lessons are: the importance of building relationships with local urology teams, including all men with the diagnosis of CRPC as documented by a medical oncologist or urologist, reducing questionnaire burden, capturing symptom scores in clinic, actively following up patients by phone, and recording all reasons for drop-out or lost to follow-up. These lessons can now be implemented to improve future studies involving this demographic.

Context: Fatigue is common in life-limiting cancer. Methylphenidate (MPH), a psychostimulant, may be a useful therapy. Gathering evidence in patients with advanced cancer can be challenging., Objectives: To determine if MPH improves cancer-related fatigue in people with advanced cancer., Methods: N-of-1 trials are multicycle, double-blind, randomized, controlled crossover trials using standardized measures of effect in individuals. They are normally used to assess treatment effects in individuals. Aggregated N-of-1 trials from participants with end-stage cancer suffering fatigue were used to assess the group effect of MPH, producing an estimate of equivalent power to a parallel-group randomized controlled trial (RCT) but requiring less than half of the sample size. Up to three cycles of MPH 5 mg twice daily (three days) vs. identical placebo (three days) capsules were offered to participants. Primary outcome was improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale and the Wu Cancer Fatigue Scale. Analysis used Bayesian statistical methods using intention-to-treat principles., Results: Forty-three participants completed 84 cycles of MPH and placebo in random order, exceeding sample size estimates. Overall, MPH did not improve fatigue (mean difference 3.2; 95% credible interval -2.0, 9.0; posterior probability of favorable effect 0.890). Eight participants showed important improvement, and one participant showed important worsening of fatigue on MPH. There were no features that distinguished participants whose fatigue responded to MPH compared with those who did not., Conclusion: MPH does not improve fatigue in the population of patients with end-stage cancer. Aggregated N-of-1 trial methodology is feasible and produces population-based sample estimates with less than half the sample size required for the equivalent parallel-group RCT. It also identified individuals who did and did not respond to MPH, which is a feature difficult to achieve in a standard RCT. The study was registered with the Australian Clinical Trials Registry (12609000794202)., (Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine if patients with advanced cancer are interested in participation in palliative care research, particularly RCTs, and the importance of demographic factors in decision making. It sought relatives' views towards supporting trial entry, and assessed if demographic factors can predict participation., Methods: A questionnaire was developed through multiprofessional focus groups, patient and relative interviews and pilot studies. Consecutive patients known by the palliative care service to have advanced disease were approached. Relatives of consenting patients completed a parallel survey. K-means cluster analysis was used to differentiate between those willing and unwilling to participate. Multivariate logistic regression identified demographic factors predicting willingness., Results: One hundred and one patients and 100 relatives were included. 92% of patients would participate in studies involving simple interventions, whereas only 26% would consider studies of complex interventions. A similar pattern was observed for relative support. Over 75% of participants expressed altruistic views. Concepts of 'randomisation', 'placebo-control' and 'blinding' deterred about one-half. Many were prepared to complete short questionnaires, accept extra medications, investigations, hospital visits or admissions within a trial context but the possibility of side-effects was a major deterrent. Patient age was the only significant predictor of willingness to participate, with older patients less likely to participate., Conclusion: Despite the likely absence of individual benefit, many patients appear willing to participate in palliative care research. Trial design and the possibility of side-effects proved very influential in their decision making. Clinical trials in palliative care are more likely to be successful if developed in accordance with the views of patients and their relatives.

Context: Medications commonly used for symptom control along with other known risk factors have the potential to prolong ventricular repolarization as measured by the QT interval (the time from the start of the Q wave to the end of the T wave) on a standard electrocardiogram (ECG).Objectives: To document the prevalence of a prolonged QT interval corrected for heart rate (QTc) interval in the palliative/oncology setting, compare automatic ECG QTc measurements with manual readings and identify any correlation between QTc prolongation and the use of drugs or other risk factors.Methods: A convenience sample of consecutive patients with cancer, admitted under or known to the palliative/supportive care teams in two metropolitan hospitals, and willing to provide an ECG recording and basic demographic information including QTc risk factors were included. Both automated and manually calculated QTc intervals were recorded. Multivariable analysis was used to determine risk factors independently associated with prolonged QTc intervals.Results: Of the 389 participants, there was a significant difference in mean QTc between sites using automated but not manual calculations. Manual readings were therefore used with predetermined cutoffs of 0.44 seconds (males) and 0.46 seconds (females). Seventy-two (18.5%) of the participants had a prolonged QTc with six (1.5%) having a prolongation of >0.50 seconds. At-risk drugs were being taken by 218 participants (56.0% of total cohort). Factors shown to be associated with QTc prolongation included age, gender, performance status, and hypocalcemia. No specific medication was associated with increased risk.Conclusion: Although almost 20% of patients receiving palliative care had prolongation of QTc, the possibility of serious consequences appeared to be low despite the frequent occurrence of risk factors. [ABSTRACT FROM AUTHOR]

Abstract: Context: Haloperidol is used commonly for the control of nausea and vomiting (N/V) in palliative care patients, but there is very little evidence to support its use. Objectives: To assess the efficacy of haloperidol as an antiemetic in patients with cancer and N/V not related to cancer treatment. Methods: Patients with an N/V score of at least 1 on a 4-point scale were prescribed either oral or subcutaneous haloperidol. N/V and toxicity were assessed daily for the duration of the study (maximum five days) by both the patient and an observer (health professional). Results: At Day 2, 33 of 42 (79%) treated patients were assessable for response. Eight (24%; 95% confidence interval [CI]: 10%–39%) patients had complete control of N/V and 12 (36%; 95% CI: 20%–53%) had partial control, giving an overall response rate of 61% (95% CI: 44%–77%). At Day 5, 23 patients were assessable for response. The overall response rate was 17 of 23 (74%; 95% CI: 56%–92%). If all patients are included in the response analysis, the overall response rates at Days 2 and 5 were 47% and 40%, respectively. Conclusion: Haloperidol has some efficacy in the treatment of N/V in this patient group. The results from this uncontrolled study provide pilot data from which to plan future controlled trials of antiemetics in the palliative care population. [Copyright &y& Elsevier]