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Clinical Trial: Carotenoid Rich Diet in Treating Cervical Dysplasia
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Cervical Cancer | Behavior: Carotenoid-rich diet | Phase II |
MedlinePlus related topics: Cervical Cancer
Study Type: Interventional
Study Design: Prevention
Official Title: Phase II Prevention Study of a Carotenoid Rich Diet in Patients With Grade I or II Cervical Intraepithelial Dysplasia
Study start: October 1997
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).
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years - 55 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--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
--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
--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
Location Information
California
University of California San Diego Cancer Center, La Jolla, California, 92093-0658, United States
Cheryl L. Rock, Study Chair, UCSD Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Rock CL. Carotenoids: biology and treatment. Pharmacol Ther. 1997 Sep;75(3):185-97. Review.
Gamboa-Pinto AJ, Rock CL, Ferruzzi MG, Schowinsky AB, Schwartz SJ. Cervical tissue and plasma concentrations of alpha-carotene and beta-carotene in women are correlated. J Nutr. 1998 Nov;128(11):1933-6.
Rock CL. Dietary Reference Intakes, antioxidants, and beta carotene. J Am Diet Assoc. 1998 Dec;98(12):1410-1. Review. No abstract available.
Ferruzzi MG, Sander LC, Rock CL, Schwartz SJ. Carotenoid determination in biological microsamples using liquid chromatography with a coulometric electrochemical array detector. Anal Biochem. 1998 Feb 1;256(1):74-81.
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003094
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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