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Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer Clinical research trials and Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer  Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
For Condition: Hypopharyngeal Cancer,Oropharyngeal Cancer,Laryngeal Cancer,lip and oral cavity cancer
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to study the effectiveness of fruit and vegetable extracts in preventing the recurrence of stage I, stage II, or stage III head and neck cancer.
Details: OBJECTIVES: - Compare the disease-free survival of patients with stage I-III head and neck cancer treated with fruit and vegetable extracts vs placebo. - Compare the effect of these extracts on biomarkers (p27 expression, cell proliferation of Ki-67, DNA damage, and T-cell function) in these patients. - Correlate changes in biomarkers with other factors (e.g., site and stage of the original tumors, tobacco/alcohol use, or depression) in patients treated with these extracts. - Compare serum carotenoids and antioxidant levels (vitamins A, C, and E) at baseline and posttreatment in patients treated with these extracts. 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). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral fruit and vegetable extracts twice daily. - Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Curatively treated stage I-III squamous cell carcinoma of the upper aerodigestive tract of 1 of the following primary sites: - Oral cavity - Oropharynx - Hypopharynx - Larynx - Disease-free for at least 6 months and no more than 3 years after completion of surgery, radiotherapy, and/or chemotherapy - No synchronous tumors PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% OR - Zubrod 0-1 Life expectancy - At least 6 months Hematopoietic - Hemoglobin greater than 10 g/dL - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - SGOT less than 40 U/L - SGPT no greater than 56 U/L Renal - Creatinine no greater than 1.5 mg/dL Other - No other concurrent malignancy - No other serious medical or psychiatric illness that would preclude giving informed consent - No nausea grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - More than 24 weeks since prior chemotherapy - No concurrent chemotherapy - No other concurrent chemopreventive agents Endocrine therapy - More than 24 weeks since prior hormonal therapy Radiotherapy - See Disease Characteristics - More than 24 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - More than 24 weeks since prior surgery - No concurrent surgery Other - More than 6 months since prior investigational agents - More than 2 months since prior high-dose vitamins (i.e., 10 times the recommended daily allowance [8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of vitamin E])
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JenniferHu, Study Chair, Comprehensive Cancer Center of Wake Forest University
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Additional Information:
Study ID Numbers: CDR0000310184; CCCWFU-0112,CCCWFU-60A02,CCCWFU-BG03-161
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064298
Other Hypopharyngeal Cancer Studies:
1. Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer
3. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
4. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
5. Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Related Studies:
Other Hypopharyngeal Cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
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