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.
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
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 5 years.
DISEASE CHARACTERISTICS: Histologically proven cervical intraepithelial dysplasia, grade
CIN II, or CIN I by repeat cytology No invasive carcinoma by Pap smear No positive
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 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
Cheryl L. Rock, PhD, RD
University of California, San Diego