Evidence Explorer · MS-N304 · Hormone-derived supplements · Supportive care · Appraised 11 November 2026
A double-blind trial of melatonin 20 mg nightly in advanced lung or gastrointestinal cancer was stopped for futility and found no improvement in appetite, weight, quality of life or survival.
Evidence at a glance
- Evidence label: Randomized negative evidence
- Benefit: No demonstrated benefit for appetite, weight, quality of life, toxicity or survival over 28 days.
- Certainty: Moderate for no short-term benefit in the studied cachectic population; the trial was small because it stopped at interim analysis.
- Risk: Drowsiness and medicine interactions matter; long-term safety is uncertain and over-the-counter product content can be unreliable.
- Goal: Appetite/cachexia symptom support; not cancer control.
What was studied
Design: Adults with advanced lung or gastrointestinal cancer, appetite score at least 4/10 and at least 5% weight loss were randomized to melatonin 20 mg nightly or placebo for 28 days (NCT00513357).
Results: The trial stopped after an interim analysis of 48 participants for futility. There were no significant differences in appetite (p=0.78), weight (p=0.17), quality of life (p=0.95), treatment toxicity or survival; median survival was 140 versus 134 days (p=0.43).
Interpretation: Earlier uncontrolled or small studies do not outweigh this direct placebo-controlled negative result for cachexia.
What this evidence cannot establish
The study does not support melatonin as a treatment for cancer cachexia or as a way to prolong survival.
This record does not address lower-dose melatonin for insomnia, which is a different clinical question.
Safety and practical context
Melatonin can cause daytime drowsiness, headache or dizziness. Extra caution is appropriate with sedatives, anticoagulants, epilepsy and in older adults.
Long-term safety is not established, and supplement labels may not accurately reflect melatonin content.
Questions for the care team
- Is the goal sleep, appetite or cancer control? Those require separate evidence.
- Could melatonin worsen daytime sedation or interact with anticoagulants or seizure medicines?
- What evidence-based cachexia assessment and nutrition support are available?
Sources and identifiers
- Randomized cachexia trial (PMID 23439759)
- Full text (PMCID PMC3607670)
- ClinicalTrials.gov NCT00513357
- NCCIH: Melatonin
Funding and conflicts: The published report should be consulted for full funding and conflict details; these were not completely reproduced in the abstract.
Source access: Original reports, abstracts/full text where available, registries and authoritative safety sources checked 11 November 2026. Full text and registry information were available for the primary trial.
This educational evidence record is not a personal treatment recommendation. Symptom or toxicity findings do not establish tumor response, delayed recurrence or longer survival; laboratory and animal findings are not proof of clinical benefit.
