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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064298 |
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.
Condition | Intervention | Phase |
Head and Neck Cancer |
Drug: fruit and vegetable extracts Drug: placebo |
Phase II |
MedlinePlus related topics: | Cancer Head and Neck Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients |
Estimated Enrollment: | 200 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive oral fruit and vegetable extracts twice daily.
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Drug: fruit and vegetable extracts
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo twice daily.
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Drug: placebo
Given orally
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OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to tobacco use (yes vs no), alcohol consumption (yes vs no), and tumor stage at diagnosis (I vs II vs III vs IVA vs IVB). Patients are randomized to 1 of 2 treatment arms.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Curatively treated stage I-IVB squamous cell carcinoma of the upper aerodigestive tract of 1 of the following primary sites:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Show 28 Study Locations |
Wake Forest University |
National Cancer Institute (NCI) |
Study Chair: | Steven A. Akman, MD | Wake Forest University |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000310184, CCCWFU-0112, CCCWFU-60A02, CCCWFU-BG03-161 |
First Received: | July 8, 2003 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00064298 |
Health Authority: | Unspecified |
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