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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 is a Phase 3 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 80 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02332928
The ClinicalTrials.gov registry entry for NCT02332928 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02332928 reports 0 study locations.
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.
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