Trial Information

Carotenoid-Rich Diet Trial to Reverse CIN II

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.