Melatonin supplementation for quality of life in older patients with advanced cancer: a randomized controlled trial.

The MEQAPAG trial was prematurely terminated due to futility before reaching full enrollment.

• 123 patients were included in the study between July 2015 and January 2021
• Only 61% (n=59) of patients were assessable and considered as compliant, defined as at least two months of supplementation
• 30 patients were allocated to the experimental group and 29 to the control group among compliant patients
• Median age was 76 years (range [70, 88])

Melatonin supplementation at 2 mg/day for 90 days did not produce any significant improvement in global quality of life as measured by the EORTC QLQ-C30.

• Primary endpoint was QoL assessment using the EORTC QLQ-C30 global score before and after supplementation
• No difference in the QLQ-C30 questionnaire global score was shown between experimental and control groups
• The intervention consisted of 2 mg/day melatonin taken 1-2 hours before bedtime and after a meal for the first three months of a new systemic treatment line
• The trial was a multi-centre, double-blind, randomized placebo-controlled design

Melatonin supplementation at 2 mg/day was found to be safe in older patients with advanced cancer.

• The study population consisted of patients aged ≥70 years undergoing systemic treatment
• Safety was assessed as one of the secondary objectives
• No safety concerns were reported as leading to trial discontinuation
• The paper states supplementation 'was safe' in this older cancer population

Urinary melatonin metabolite (aMT6s) concentrations were measured and reported in older cancer patients following supplementation.

• After supplementation, the aMT6s concentration in the experimental group was 8.4 ng/mg creatinine (range [0.15, 201], IQI [0.99, 105])
• The authors describe urinary aMT6s concentration data as 'novelty data' for older cancer patients
• aMT6s (6-sulfatoxymelatonin) is a urinary metabolite used as a proxy for melatonin levels
• Urinary melatonin concentrations were evaluated as part of the secondary objectives

The trial investigated melatonin supplementation effects on sleep as a secondary outcome in older cancer patients.

• Impact of supplementation on sleep was included among the secondary objectives
• Patients were ≥70 years old with advanced cancer undergoing a new line of systemic treatment
• The sleep assessment was conducted alongside QoL, safety, survival, and urinary melatonin concentration evaluations
• Specific sleep outcome results are not detailed in the abstract