Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double‐blind placebo‐controlled crossover trial

Abstract

BACKGROUND:Patients with advanced cancer often experience fatigue and other symptoms that negatively impact their quality of life. The current trial investigated the effect of melatonin on fatigue and other symptoms in patients with advanced cancer. METHODS: Patients who were aged 18 years, had a histologically confirmed stage IV cancer (TNM Classification), and who reported feeling significantly tired were recruited from the palliative care unit at the study institution. The study was a double-blind, randomized, placebo-controlled crossover trial. Patients received 1 week of melatonin at a dose of 20 mg or a placebo orally each night, before crossing over and receiving the opposite treatment for 1 week. Between the 2 periods, a washout period of 2 days was implemented. Outcomes were measured using the Multidimensional Fatigue Inventory (MFI-20) and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Physical fatigue from the MFI-20 was the primary outcome. The primary analysis was a complete complier analysis (ie, it included only those patients who had consumed at least 5 capsules per week and who had answered the MFI-20 on days 1, 7, 10, and 17). Sensitivity analysis using multiple imputations including all randomized patients and all patients completing the intervention were conducted. RESULTS: A total of 72 patients were randomized. Fifty patients completed the intervention and 44 patients were complete compliers. No significant differences between the placebo and melatonin periods were found for physical fatigue, secondary outcomes, or explorative outcomes. CONCLUSIONS: In the current study, oral melatonin at a dose of 20 mg was not found to improve fatigue or other symptoms in patients with advanced cancer. Cancer 2015;121:3727-36.

Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression

“…In 11 trials, some of the data needed for meta-analysis were not published in the trial paper; therefore, we sought contact with authors. We retrieved the necessary information from four of the 11 studies, making the number of trials available for quantitative analysis 2322–29 31–34 39 41–47 49–51 (online supplementary material for details on rejected articles).…”

Clinical impact of melatonin on breast cancer patients undergoing chemotherapy; effects on cognition, sleep and depressive symptoms: A randomized, double-blind, placebo-controlled trial

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Melatonin for the prevention and treatment of cancer

“…However, a double-blind, placebo-controlled study reported that short-term melatonin treatment did not produce any significant influence on the estradiol and IGF-1/IGBBP-3 levels in women with a prior history of stages 0-III breast cancer [198]. Furthermore, another double-blind placebo-controlled crossover trial which included 72 patients suggested that 20 mg oral melatonin administration was not able to improve fatigue or other symptoms in patients with advanced cancer [199]. …”