Carotenoid Rich Diet in Treating Cervical Dysplasia
Recruitment status was Active, not recruiting
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||May 6, 2012|
|Start Date ICMJE||October 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003094 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Carotenoid Rich Diet in Treating Cervical Dysplasia|
|Official Title ICMJE||Carotenoid-Rich Diet Trial to Reverse CIN II|
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 both groups.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 5 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Prevention|
|Condition ICMJE||Cervical Cancer|
|Intervention ICMJE||Other: preventative dietary intervention|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||240|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years to 55 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003094|
|Other Study ID Numbers ICMJE||CDR0000065806, UCSD-960928, NCI-P97-0100|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of California, San Diego|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||August 2007|
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