Expired Study
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La Jolla, California 92093


Purpose:

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.


Study summary:

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). 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.


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 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 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


NCT ID:

NCT00003094


Primary Contact:

Study Chair
Cheryl L. Rock, PhD, RD
University of California, San Diego


Backup Contact:

N/A


Location Contact:

La Jolla, California 92093
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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