Carotenoid Rich Diet in Treating Cervical Dysplasia

Phase 2

Withdrawn

• Conditions: Cervical Cancer

• Registration Number: NCT00003094
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-04-26
• Study First Posted: 2004-04-27
• Status Verified: 2007-08
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States