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Home > "C" Clinical Trials Conditions > Carotenoid Rich Diet in Treating Cervical Dysplasia  Carotenoid Rich Diet in Treating Cervical Dysplasia
Carotenoid Rich Diet in Treating Cervical Dysplasia
For Condition: Cervical Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , UCSD Cancer Center
Synopsis: RATIONALE: A diet rich in carotenoids may be an effective treatment for cervical dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia.
Details: OBJECTIVES: I. Determine whether a carotenoid rich diet will cause a significant increase in the regression of disease in patients with grade I or II cervical intraepithelial dysplasia. II. Determine whether the regression of disease in this patient population is reflected in the modulation of intermediate biological markers (viral genome copy number of human papilloma virus (HPV) and HPV E6/E7 expression). PROTOCOL OUTLINE: This is a randomized, controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive dietary counseling and eat 5-10 servings of carotenoid rich fruit and vegetables each day for a year. Arm II: Patients receive no counseling and maintain their normal diet. Carotenoid levels, HPV status, progression of cervical dysplasia, and diet (by food frequency checklist and food diary) are monitored in both groups. PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven cervical intraepithelial dysplasia, grade CIN II, or CIN I by repeat cytology - No invasive carcinoma by Pap smear - No positive endocervical curettage --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: At least 6 months since prior cauterization, cryosurgery, laser, or conization of the cervix --Patient Characteristics-- - Age: 18 to 55 (premenopausal) - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No concurrent beta carotene supplements; Not pregnant or nursing; No prior malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CherylRock, Study Chair, UCSD Cancer Center
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Additional Information:
Study ID Numbers: CDR0000065806; UCSD-960928,NCI-P97-0100
Study Start Date: October 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003094
Other Cervical Cancer Studies:
1. Epoetin beta in Treating Anemia in Patients With Cervical Cancer
2. Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
3. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
4. Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
5. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Related Studies:
Other Cervical Cancer Clinical Trials
Other California Clinical Trials
Other La Jolla Clinical Trials
Carotenoid Rich Diet in Treating Cervical Dysplasia
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