{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T02:10:31Z","timestamp":1792203031978,"version":"4.4.0"},"reference-count":28,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2013,4,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores \u2265 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss \u2265 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia\/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z &lt; 0.39 (P \u2265 .348) and reject the null hypothesis if z &gt; 2.54 (P \u2264 .0056). <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2012.43.6766","type":"journal-article","created":{"date-parts":[[2013,2,26]],"date-time":"2013-02-26T06:45:20Z","timestamp":1361861120000},"page":"1271-1276","source":"Crossref","is-referenced-by-count":101,"title":["Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial"],"prefix":"10.1200","volume":"31","author":[{"given":"Egidio","family":"Del Fabbro","sequence":"first","affiliation":[{"name":"All authors: The University of Texas MD Anderson Cancer 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