Evidence map›Paper›PMID 23439759›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: a double-blind placebo-controlled trial.

Egidio Del Fabbro, Rony Dev, David Hui, Lynn Palmer, Eduardo Bruera

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02619266 (The Traditional Chinese Medicine Department of Xin Qiao Hospital), which is not on this map. Cited by 40 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 13 pooled it
6.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02619266 phase2 / phase3unknown statusnot on this mapstarted 2015, after this paper: background citation

The Traditional Chinese Medicine Department of Xin Qiao Hospital

TypeinterventionalSponsorXinqiao Hospital of ChongqingRan2015 to 2017Enrolled160ConditionsAnorexia, Cancer CachexiaArmsAcupuncture, Sham Acupuncture, Megestrol Acetate, Placebo(Megestrol Acetate)
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 13 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Influence of melatonin supplementation on cancer-related fatigue: a meta-analysis of randomized controlled trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Pooled it
  3. Melatonin in cancer treatment.The Cochrane database of systematic reviews · 2025
    Pooled it
  4. Pooled it
  5. SEOM clinical guidelines for cancer anorexia-cachexia syndrome (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Trial
  15. The effect of melatonin on sleep and quality of life in patients with advanced breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
    Trial
  16. Trial
  17. Trial
  18. Cancer cachexia: molecular basis and therapeutic advances.Signal transduction and targeted therapy · 2026
    Review
  19. Melatonin: A Review of the Evidence for Use in Hospital Settings.Pharmacology research & perspectives · 2025
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Egidio Del FabbroThe University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Rony Dev
David Hui
Lynn Palmer
Eduardo Bruera
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Methylphenidate for Fatigue in Advanced Cancer PatientsR01NR010162 · NINR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BRUERA, EDUARDO · 2006 to 2009
$1.3M
Morphine versus Methadone as First Line Strong Opioid for Cancer PainR01CA124481 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BRUERA, EDUARDO · 2007 to 2009
$1.2M
NCI NIH HHS R01CA1222292.01NCI NIH HHS R01 CA124481NCI NIH HHS R01CA124481-01NINR NIH HHS R01 NR010162NINR NIH HHS R01NR010162-01A1
6 · The paper itself

Abstract

purposePrior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. PATIENTS AND

methodsWe performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056).

resultsAfter interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28.

conclusionIn cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.

Indexed as

AdultAgedAged, 80 and overAntioxidantsAppetiteBody WeightCachexiaDepressionDouble-Blind MethodFatigueFemaleHumansMaleMelatoninMiddle AgedNeoplasmsAntioxidantsMelatonin

Identifiers

PMID23439759
PMCPMC3607670
OpenAlexW2149624927

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.