This study included patients diagnosed with stage 4 cancer (age ≥18 years) who reported feeling significantly tired. Patients were recruited from the palliative care unit at a study institution and enrolled in the double-blind, randomized, placebo-controlled trial.
Participants in the study were administered a dose of 20 mg melatonin or an oral placebo each night for 1 week. After a washout period of 2 days occurred, the patients received the other dosage not administered in week one.
The Multidimensional Fatigue Inventory (MFI-20) primarily assessed physical fatigue, and primary analysis was conducted using complete complier analysis.
Overall, 72 patients were randomized, 50 completed the intervention, and 44 were complete compliers (meaning they consumed at least 5 capsules/week and answered the MFI-20 on days 1, 7, 10, and 17).
Results showed no significant differences in physical fatigue or other outcomes between the melatonin and placebo periods.
Lund Rasmussen, C., Klee Olsen, M., Thit Johnsen, A., Aagaard Petersen, M., Lindholm, H., Andersen, L., Villadsen, B., Groenvold, M. and 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. doi: 10.1002/cncr.29563