Rasmussen, C.L., Olsen, M.K., Johnsen, A.T., Petersen, M.A., Lindholm, H., Andersen, L., . . . Pedersen, L. (2015). Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial. Cancer, 121, 3727–3736.
To determine if oral melatonin administered at night would reduce fatigue and improve sleep in patients with advanced cancer treated in a palliative care facility
This was a two-part trial. In part one, patients received either melatonin (20 mg) or placebo followed by a washout of two days, then crossed over and received the opposite of the first week of treatment. Part two was an open-label study of patients who completed part one and chose to continue melatonin. Study questionnaires were completed at the beginning and end of each treatment period (days 1, 7 ,10, and 17). In part two, study measures were obtained weekly. Patients were randomly assigned to the order in which they received melatonin or placebo.
No significant differences were noted in patient outcomes between the placebo and melatonin groups.
Melatonin administration did not improve fatigue, insomnia, or other symptoms in patients with advanced cancer.
This study did not show any improvement in fatigue or sleep as a result of melatonin.