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Trial record 2 of 298 for:    cervical cancer University of California
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Carotenoid Rich Diet in Treating Cervical Dysplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003094
First received: November 1, 1999
Last updated: May 6, 2012
Last verified: August 2007
History of Changes
  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
 Other: preventative dietary intervention
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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

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

Publications:
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.
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.

ClinicalTrials.gov Identifier: NCT00003094     History of Changes
Other Study ID Numbers: CDR0000065806, UCSD-960928, NCI-P97-0100
Study First Received: November 1, 1999
Last Updated: May 6, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013