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NCT00486304 · ClinicalTrials.gov registry record · Phase 1
Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00486304: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00486304 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00486304, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
RATIONALE: Eating a diet that is low in antioxidants may control cachexia in patients with oropharyngeal cancer. PURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and radiation therapy.
Primary Outcome
Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
Interventions
- OTHER Placebo
- OTHER ADD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00486304 record still lists
NCT00486304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00486304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00486304 about?
NCT00486304 is a clinical study titled "Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy". RATIONALE: Eating a diet that is low in antioxidants may control cachexia in patients with oropharyngeal cancer. PURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and rad...
What is the current status of trial NCT00486304?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2006-02. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00486304?
The interventions under investigation include: Placebo (OTHER), ADD (OTHER).
Who is sponsoring clinical trial NCT00486304?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00486304's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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