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NCT00064298 · ClinicalTrials.gov registry record · Phase 2
Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
A Phase 2 study of Head and Neck Cancer, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT00064298: Completed Phase 2 study of Head and Neck Cancer, sponsored by Wake Forest University Health Sciences.
NCT00064298 is a Phase 2 study of Head and Neck Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 134 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064298, a Phase 2 study of Head and Neck Cancer, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer. PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.
Primary Outcome
Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT placebo
- DIETARY_SUPPLEMENT fruit and vegetable extracts
Study Locations (20)
Missouri
- CCOP - Cancer Research for the Ozarks - Springfield
- Missouri Baptist Cancer Center - St Louis
- CCOP - St. Louis-Cape Girardeau - St Louis
California
- CCOP - Santa Rosa Memorial Hospital - Santa Rosa
- Redwood Regional Medical Group - Santa Rosa
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami - Miami
- CCOP - Mount Sinai Medical Center - Miami Beach
Illinois
- MBCCOP - JHS Hospital of Cook County - Chicago
- CCOP - Central Illinois - Decatur
Louisiana
- MBCCOP - LSU Health Sciences Center - New Orleans
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences - Shreveport
Michigan
- CCOP - Michigan Cancer Research Consortium - Ann Arbor
- CCOP - Beaumont - Royal Oak
North Carolina
- Alamance Cancer Center at Alamance Regional Medical Center - Burlington
- Hugh Chatham Memorial Hospital - Elkin
Delaware
- CCOP - Christiana Care Health Services - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2004-01-01 |
| Est. Completion | 2009-04-01 |
| Phase | Phase 2 |
What the finished NCT00064298 record still lists
NCT00064298 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00064298 names 20 study sites across 12 states, led by Missouri, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00064298 about?
NCT00064298 is a clinical study titled "Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer". RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer. PURPOSE: This randomized phase II trial is studyi...
What is the current status of trial NCT00064298?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2004-01-01. Estimated completion is 2009-04-01.
What conditions does trial NCT00064298 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT00064298?
The interventions under investigation include: placebo (DIETARY_SUPPLEMENT), fruit and vegetable extracts (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00064298?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00064298 being conducted?
This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00064298's enrollment target sits among peer trials
134 69th of 250 higher than 182 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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