Carotenoid Rich Diet in Treating Cervical Dysplasia - Full Text View

Sponsors and Collaborators:	University of California, San Diego National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003094

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	Intervention	Phase
Cervical Cancer	Procedure: preventative dietary intervention	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carotenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention
Official Title:	Carotenoid-Rich Diet Trial to Reverse CIN II

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	240
Study Start Date:	October 1997

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003094

Locations

United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658

Sponsors and Collaborators

University of California, San Diego

National Cancer Institute (NCI)

Investigators

Study Chair:

Cheryl L. Rock, PhD, RD

University of California, San Diego

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rock CL, Michael CW, Reynolds RK, Ruffin MT. Prevention of cervix cancer. Crit Rev Oncol Hematol. 2000 Mar;33(3):169-85. Review.

Ferruzzi MG, Sander LC, Rock CL, et al.: Carotenoid determination in biological micro-samples using liquid chromatography with a coulometeric electrochemical array detector. FASEB J 12(5 pt 2): A967, 1998.

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.

Gamboa-Pinto AJ, Ferruzi MG, Rock CL, et al.: Relationships between plasma and cervical tissue concentrations in young women. FASEB J 12(5 pt 2): A856, 1998.

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. Nutritional factors in cancer prevention. Hematol Oncol Clin North Am. 1998 Oct;12(5):975-91. Review.

Rock CL. Dietary Reference Intakes, antioxidants, and beta carotene. J Am Diet Assoc. 1998 Dec;98(12):1410-1. Review. No abstract available.

Rock CL. Carotenoids: biology and treatment. Pharmacol Ther. 1997 Sep;75(3):185-97. Review.

Study ID Numbers:	CDR0000065806, UCSD-960928, NCI-P97-0100
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003094
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical cancer

Study placed in the following topic categories:

Cervical intraepithelial neoplasia
Uterine Cervical Dysplasia
Carotenoids
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009