Trial · NCT00513357

Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients

NCT00513357, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2012-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients. Trials, record NCT00513357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00513357

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
NCT number: NCT00513357
Status: Completed
Phases: Phase 3
Enrollment: 82 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Gastrointestinal Cancer, Lung Cancer
Interventions: Melatonin, Placebo
First posted: 2007-08-08
Last updated: 2012-12-11
Results first posted: 2012-09-14

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Appetite as Measured by ESAS	Baseline and at 4 weeks	Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation \[± 3 days\] to 4 week evaluation \[± 3 days\], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Appetite as Measured by ESAS	Baseline and at 4 weeks		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Appetite as Measured by ESAS	Melatonin		-0.83	Standard Deviation 2.6	units on a scale
Change in Appetite as Measured by ESAS	Placebo		-1.19	Standard Deviation 2.3	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin	38
Overall Study	STARTED	Placebo	35
Overall Study	COMPLETED	Melatonin	23
Overall Study	COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Melatonin	15
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Confusion	Psychiatric disorders	Melatonin	1	38	1
other	Confusion	Psychiatric disorders	Placebo	0	34	0
other	Fatigue	General disorders	Melatonin	1	38	1
other	Fatigue	General disorders	Placebo	4	34	4
other	Nausea	Gastrointestinal disorders	Melatonin	1	38	1
other	Nausea	Gastrointestinal disorders	Placebo	2	34	2
other	Pain	General disorders	Melatonin	0	38	0
other	Pain	General disorders	Placebo	3	34	3
other	Somnolence	Nervous system disorders	Melatonin	1	38	1
other	Somnolence	Nervous system disorders	Placebo	1	34	1

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin
Total, all-cause mortality	Placebo
Total, other adverse events	Melatonin	6	38
Total, other adverse events	Placebo	15	35
Total, serious adverse events	Melatonin	2	38
Total, serious adverse events	Placebo	2	35

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23439759	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Melatonin vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00513357

GET https://conductscience.org/api/trials/v1/NCT00513357/events?page=2

API reference For AI assistants