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NCT02332928 · ClinicalTrials.gov registry record · Phase 3
Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
A Phase 3 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT02332928: Clinical Trial Phase 3 study, sponsored by Virginia Commonwealth University.
NCT02332928 is a Phase 3 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02332928, a Phase 3 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be randomized to receive either 20 mg oral melatonin or placebo the night before their first radiotherapy (RT), nightly throughout their RT, and for an additional 2 weeks following the completion of their RT. After informed consent is obtained from eligible subjects, they will then be electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3 weeks) and prior chemotherapy.
Primary Outcome
Determine if the average increase in fatigue (as measured by the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue subscale) from baseline to completion of RT is different in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plu
Interventions
- DRUG Placebo
- DRUG Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-03-25 |
| Est. Completion | 2021-06-02 |
| Phase | Phase 3 |
Why NCT02332928 stopped before completion
NCT02332928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02332928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02332928 about?
NCT02332928 is a clinical study titled "Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy". This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be randomized to receive either 20 mg oral melatonin or placebo the night before their first radiotherapy (RT), nightly throughout their RT, and for an additional 2 weeks following the completion of their RT. A...
What is the current status of trial NCT02332928?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2015-03-25. Estimated completion is 2021-06-02.
What interventions are being tested in trial NCT02332928?
The interventions under investigation include: Placebo (DRUG), Melatonin (DRUG).
Who is sponsoring clinical trial NCT02332928?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02332928's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 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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