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NCT00513357 · ClinicalTrials.gov registry record · Phase 3
Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 82
- Enrollment target
NCT00513357: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00513357 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 82 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513357, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 82 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be evaluated.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2006-06 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT00513357 record still lists
NCT00513357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00513357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00513357 about?
NCT00513357 is a clinical study titled "Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients". The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be...
What is the current status of trial NCT00513357?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 82 participants. The study started on 2006-06. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00513357?
The interventions under investigation include: Placebo (DRUG), Melatonin (DRUG).
Who is sponsoring clinical trial NCT00513357?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00513357's enrollment target sits among peer trials
82 1752nd of 2000 higher than 249 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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