Carotenoid Rich Diet in Treating Cervical Dysplasia
|ClinicalTrials.gov Identifier: NCT00003094|
Recruitment Status : Withdrawn (Study was halted prematurely, prior to enrollment of first participant)
First Posted : April 27, 2004
Last Update Posted : May 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: preventative dietary intervention||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Carotenoid-Rich Diet Trial to Reverse CIN II|
|Study Start Date :||October 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003094
|United States, California|
|University of California San Diego Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Study Chair:||Cheryl L. Rock, PhD, RD||University of California, San Diego|