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Objective: Anticipatory nausea and vomiting are unpleasant symptoms observed before undergoing chemotherapy sessions. Less is known about the occurrence of symptoms since the advent of the new neurokinin-1 antagonist., Methods: This prospective cohort study was performed at a single Brazilian Institution. This study included breast cancer patients who received doxorubicin and cyclophosphamide chemotherapy and an appropriate antiemetic regimen (dexamethasone 10 mg, palonosetron 0.56 mg, and netupitant 300 mg in the D1 followed by dexamethasone 10 mg 12/12 h in D2 and D4). Patients used a diary to record nausea, vomiting, and use of rescue medication in the first two cycles of treatment. The prevalence of anticipatory nausea and vomiting was assessed before chemotherapy on day 1 of C2., Results: From August 4, 2020, to August 12, 2021, 60 patients were screened, and 52 patients were enrolled. The mean age was 50.8 (28-69) years, most had stage III (53.8%), and most received chemotherapy with curative intent (94%). During the first cycle, the frequency of overall nausea and vomiting was 67.31%, and that of severe nausea and vomiting (defined as grade>4 on a 10-point visual scale or use of rescue medication) was 55.77%. Ten patients had anticipatory nausea and vomiting (19.23%). The occurrence of nausea and vomiting during C1 was the only statistically significant predictor of anticipatory nausea and vomiting (OR=16, 95%CI 2.4-670.9, p=0.0003)., Conclusion: The prevalence of anticipatory nausea is still high in the era of neurokinin-1 antagonists, and failure of antiemetic control in C1 remains the main risk factor. All efforts should be made to control chemotherapy-induced nausea or nausea and vomiting on C1 to avoid anticipatory nausea.

Objective: To estimate the incidence and to evaluate risk factors for antineoplastic nausea and vomiting with high and moderate emetogenic chemotherapy in adult patients in the first treatment cycle., Methods: Prospective cohort study with follow-up of 269 adults during the first cycle of antineoplastic chemotherapy. The incidence of nausea and vomiting was evaluated in the acute phase (0-24 hours), in the late phase (24 hours-5th day) and in the total phase (0-5th day)., Results: In total, 152 patients underwent high emetogenic chemotherapy and 117 moderate emetogenic chemotherapy. The relative frequency of nausea was higher when compared with vomiting in the acute phase (p < 0.001) and in the late phase (p < 0.001). The risk factors identified were: age group ≤ 49 years (odds ratio = 0.47; 95%CI 0.23-0.95) and 50-64 years (odds ratio = 0.45; 95%CI 0.23-0.87), tobacco use (odds ratio = 0.35; 95%CI 0.14-0.88), and high emetogenic chemotherapy (odds ratio 0.55; 95%CI 0.31-0.95)., Conclusion: The incidence of nausea was higher than that of vomiting, and adverse effects were more frequent in the late phase. The results suggest the risk factors for chemotherapy-induced nausea and vomiting are tobacco, age (young adults), and high emetogenic chemotherapy.

Objective: Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population., Methods: Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments included adverse events leading to permanent discontinuation of nintedanib and serious adverse events., Results: The EAP involved 57 patients at eight centers. Most patients were male (77.2%) and white (87.7%). At baseline, mean (SD) age was 70.7 (7.5) years and FVC was 70.7 (12.5) % predicted. Mean (SD) exposure to nintedanib was 14.4 (6.2) months; maximum exposure was 22.0 months. The most frequently reported adverse events considered by the investigator to be related to nintedanib treatment were diarrhea (45 patients, 78.9%) and nausea (25 patients, 43.9%). Adverse events led to permanent discontinuation of nintedanib in 16 patients (28.1%). Sixteen patients (28.1%) had a serious adverse event., Conclusion: In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials.

Nausea and vomiting are frequent side effects associated with chemotherapy treatments. The aim of this study was to evaluate the efficacy of laser acupuncture in relieving nausea and vomiting in children and adolescents undergoing laser treatment. This is an experimental, randomized, single-blind study. The research was carried out at the INCA (Instituto Nacional de Câncer), a reference institution in the control and treatment of cancer, located in the city of Rio de Janeiro, Brazil. The research project was approved by the INCA Research and Ethics Committee under Registration No. 164/14 and CAAE 3374551.0.3001.5274. Children and adolescents between the ages of 6 and 17 years who were undergoing chemotherapy with drugs of high and medium degrees of emetogenic toxicity were selected. The participants were divided into two groups, A and B. In A, the active acupuncture was applied, and in B, the placebo acupuncture was applied. Analysis of the data indicated that there was significant relief from nausea in the intervention group when compared with the placebo group. A decrease in the number of episodes of vomiting on the second and third days of chemotherapy was also observed. On Days 1, 4, and 5, there was no significant difference in the number of episodes of vomiting in the intervention group as compared with the placebo group. The study concluded that laser acupuncture was effective in relieving nausea within 5 days of chemotherapy and in reducing the number of episodes of vomiting on Days 2 and 3 after chemotherapy.

Objective: This study aims to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to quality of life (QOL) in patients with cancer receiving antineoplastic treatment., Methods: Severity of chemotherapy-induced nausea and vomiting (CINV) was measured by Common Terminology Criteria for Adverse Events (CTCAE) and a numerical scale. QOL was assessed using the Functional Assessment of Cancer Therapy-General questionnaire., Key Findings: Of the 50 patients studied, 60.0% reported nausea (40.0% CTCAE grade 1; 66.7% moderate intensity on numerical scale) and 30.0% reported vomiting (46.7% CTCAE grades 1 and 2, each; 66.7% moderate intensity on numerical scale). CINV did not influence overall QOL., Conclusion: The frequency of CINV was high. There was no association between nausea/vomiting and overall QOL., (© 2015 Royal Pharmaceutical Society.)

Background: Cutaneous leishmaniasis (CL) is treated with parenteral drugs for decades with decreasing rate cures. Miltefosine is an oral medication with anti-leishmania activity and may increase the cure rates and improve compliance., Methodology/principal Findings: This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sb(v)) in the treatment of patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients were enrolled in the trial; 60 were assigned to receive miltefosine and 30 to receive Sb(v). Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sb(v) group and 75% in the miltefosine group (difference of 21.7%, 95% CI 0.08% to 42.7%, p = 0.04). Miltefosine was more effective than Sb(v) in the age group of 13-65 years-old compared to 2-12 years-old group (78.9% versus 45% p = 0.02; 68.2% versus 70% p = 1.0, respectively). The incidence of adverse events was similar in the Sb(v) and miltefosine groups (76.7% vs. 78.3%). Vomiting (41.7%), nausea (40%), and abdominal pain (23.3%) were significantly more frequent in the miltefosine group while arthralgias (20.7%), mialgias (20.7%) and fever (23.3%) were significantly more frequent in the Sb(v) group., Conclusions: This study demonstrates that miltefosine therapy is more effective than standard Sb(v) and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil., Trial Registration: Clinicaltrials.gov Identifier NCT00600548.

Objective: Azathioprine (AZA) is frequently used in Crohn's disease (CD) therapy. This paper aimed to evaluate the frequency, evolution and management of AZA side effects in CD patients., Methods: One hundred and six CD patients under AZA therapy were evaluated prospectively from January 2002 to December 2006. Clinical and demographic data were recorded, together with a monthly laboratory control of hematological or other adverse reactions by means of clinical evaluation. Comparison was carried out between groups with and without side effects., Results: At least one adverse reaction was found in 56 (52.7%) of the patients studied and required a transient drug reduction; 18 (17%) had to definitely stop use of AZA, often because of hypersensitivity reactions. Nausea, vomit, although slight, occurred in 29 (27.4%). The black race and those with co-morbidities had more gastric intolerance than Caucasians and those without other associated disease (p=0.04). Leucopoenia was the more frequent side effect observed, occurring in 36 (34%). The period of AZA use was longer for patients with leucopoenia than for those without (p=0.001), while the mean dose of AZA was lower for those with leucopoenia when compared to non-leucopoenics (p=0.005). No serious infections, malignancy or death was noticed as a consequence of AZA use., Conclusion: In this study use of AZA in therapy for Crohn's disease disclosed that the drug is satisfactorily safe as long as periodical clinical and laboratory supervision is carried out during treatment.

Purposes: To determine both the incidence of adverse reactions in patients who underwent fluorescein angiography for the first time and to determine whether systemic arterial hypertension, diabetes or allergy history increases the chance of reaction to intravenous fluorescein., Methods: Data collection was carried out between January 2001 and October 2002 in Recife, Brazil. Patients with prior fluorescein angiography history, pregnant patients or patients in use of corticosteroids, immunosuppressive or antihistamine drugs were excluded., Results: Out of 1,500 enrolled patients, 1,039 (69.3%) underwent the test for the first time. The mean age was 58 +/- 16 years and the median age was 60 years. Of these, 628 (60.4%) were women. Nausea occurred in 71 (6.83%) patients, vomiting in 14 (1.35%), urticaria in 11 (1.06%), bronchospasm in 4 (0.38%) and laryngeal edema in 1 (0.01%). Five patients presented more than one adverse reaction. Higher incidences of adverse reactions were observed in diabetic patients [p<0.002, RR=1.80 (CI=1.24-2.60)], patients with systemic arterial hypertension [p<0.002, RR=1.84 (CI=1.26-2.71)] and patients with allergy history [p<0.001, RR=3.90 (CI=2.70-5.63)]., Conclusions: A cumulative incidence of 9.72% adverse reactions was observed in patients who had undergone this test for the first time. The presence of the allergy history, diabetes or systemic arterial hypertension increased the incidence of adverse reactions to the dye.

Background: 5HT-3 antagonists and corticosteroids control less than 50% of delayed chemotherapy induced nausea and vomiting (CINV) episodes., Materials and Methods: Two pilot phase II studies were conducted at our institution in which all patients received ondansetron 16 mg and dexamethasone 20 mg before highly and moderately emetogenic chemotherapy on day 1. Patients on study 1 received metoclopramide 10 mg PO q8 h, granisetron 0.5 mg PO QD and dexamethasone 8 mg QD on days 2 and 3, whereas only metoclopramide was continued on the same schedule on day 4. On study 2, patients received the same medications, but no drugs were given on day 2, and the same treatment schedule was given to them but from days 3 to 5 instead. Patients were interviewed on days 1 and 6., Results: Twenty-one patients participated on each study. There were no significant clinical differences between these two studied populations. Complete CINV control occurred from days 2 to 5 in 23.1% (95% CI: 8 to 47%) on study 1 vs 61.9% (95% CI: 38 to 81%) of the patients on study 2. By logistic regression, complete CINV control was correlated significantly with antiemetic treatment group (p=0.011) even when we considered only patients who achieved complete CINV control during the first 24 h (p=0.031)., Conclusions: Skipping day 2 antiemetic medications does not seem to worsen delayed CINV control and may even improve it, perhaps by avoiding tachyphylaxis to these medications. A randomized controlled study is in progress to confirm these results.

This study was designed to determine the effect of a progressive muscle relaxation intervention on nausea and vomiting associated with anticancer chemotherapy. Subjects were 30 hematology patients who were hospitalized and received chemotherapy treatment at a large hospital in the interior of São Paulo, Brazil. The results indicated that progressive muscle relaxation lead to statistically significant changes in physiological and muscle conditions and in nausea and vomiting levels. Therefore, this relaxation technique may be an effective nursing intervention method to allay or alleviate nausea and vomiting in patients receiving chemotherapy. For future studies, we suggest using a control group, a homogeneous sample in terms of antiemetic and chemotherapy type and dosage, and the longitudinal following of subjects during chemotherapy.

Objectives: Chemotherapy-induced nausea and vomiting (QTNV) are very uncomfortable symptoms for patients with cancer, which can be circumvented in most of them with drug combinations containing serotonin receptor antagonists (5-HT3 receptor antagonists) such as granisetron. In an attempt to decrease costs of QTNV prophylaxis, we studied a lower dose regimen of granisetron., Patients and Methods: Sixty patients with cancer scheduled to receive moderately/highly emetogenic chemotherapy were pretreated 1 h before with 0.5 mg granisetron p.o. combined with dexamethasone 20 mg i.v., Results: We observed complete control for nausea, vomiting, and nausea and vomiting in 78% [95% confidence interval (CI), 67-89%], 61% (95% CI, 47.5-74.5%), and 58% (95% CI, 44.3-71.7%) of the patients, respectively. This regimen was very well tolerated; headache (35%), xerostomia (11%), and constipation (5%) were the most frequent adverse symptoms reported., Conclusions: The regimen with lower dose granisetron is effective for acute QTNV prophylaxis and offers a cheaper alternative for QTNV control. We feel that these encouraging results should be confirmed in a randomized comparative trial.

Disseminated germ cell testicular cancer proved to be highly sensitive to platinum-containing chemotherapy regimens. We present data concerning the treatment of advanced seminoma and nonseminomatous tumors in a developing country. We treated 30 patients with advanced germ cell testis tumors with 3 or 4 cycles of vinblastine, actinomycin D, bleomycin, cyclophosphamide and cis-platinum. Surgical resection of residual masses was done 30 days after completion of chemotherapy in 18 patients. The histology of the primary tumor was seminoma in 13 patients and nonseminomatous tumors in 17. Toxicity was mild and no treatment-related deaths occurred. All 13 patients (100 per cent) with seminoma and 12 of 17 patients (71 per cent) with nonseminomatous tumors had a complete response to chemotherapy, and 1 of 17 patients was free of disease after a debulking operation and additional chemotherapy. A total of 3 patients with seminoma and 2 with nonseminomatous tumors had recurrences 5 to 8 months after an initial complete response and received additional chemotherapy (VP-16 regimen) with or without radiotherapy. Complete clinical response was achieved in 4 of 5 patients. Median followup was 24 months (range 8 to 38 months) in the 13 patients with seminoma and 28 months (range 9 to 58 months) in those with nonseminomatous tumors, and 13 (100 per cent) and 12 (71 per cent), respectively, are alive without evidence of disease. These data suggest that the protocol of vinblastine, actinomycin D, bleomycin, cyclophosphamide and cis-platinum is highly effective and minimally toxic in the treatment of disseminated germ cell testicular cancer, inducing an 83 per cent long-lasting clinical remission. Seminomas seem to be equally or even more sensitive than nonseminomatous tumors to this platinum-containing chemotherapy regimen. Recurrence after initial complete response can be treated successfully with regimens containing VP-16.