Del Fabbro, E., Dev, R., Hui, D., Palmer, L., & Bruera, E. (2013). Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial. Journal of Clinical Oncology, 31, 1271–1276.

To compare melatonin with placebo for impact on appetite in patients with advanced cancer

Patients were randomly assigned to receive 20 mg melatonin or identical placebo daily for 28 days. Study assessments were done at baseline and at four weeks. Patients were stratified according to whether or not they were currently receiving antitumor treatment.

• The study reported on a sample of 48 patients.
• Mean patient age was 60 years, with a range of 32–86 years.
• The sample was 56% female and 44% male.
• All patients had locally recurrent or metastatic disease.

• Multisite
• Outpatient setting
• Texas

 The study was a double-blind, randomized, placebo-controlled trial.

• Edmonton Symptom Assessment Scale
• Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)
• FACIT subscale questionnaire
• Toxicity questionnaire
• Bioimpedance for body composition and weight
   

There were no significant differences between groups in symptoms or change in symptoms at four weeks. There were no differences in change in body weight or body composition. Thirty-three percent of patients were lost to follow-up.

Melatonin had no effect on appetite or other symptoms in patients with advanced cancer.

• The study had a small sample size, with less than 100 patients.
• Patient withdrawals were 10% or greater.

Findings of this study do not support the use of melatonin to improve appetite or other symptoms in patients with advanced cancer.