Carotenoid Rich Diet in Treating Cervical Dysplasia

NCT00003094 | Withdrawn Phase 2

• 3 other identifiers: UCSD-960928CDR0000065806NCI-P97-0100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

cervical cancer

Interventions

preventative dietary intervention OTHER

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Related Publications (7)

• Rock CL, Michael CW, Reynolds RK, Ruffin MT. Prevention of cervix cancer. Crit Rev Oncol Hematol. 2000 Mar;33(3):169-85. doi: 10.1016/s1040-8428(99)00073-6.

  PMID: 10789491 BACKGROUND

• 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. doi: 10.1006/abio.1997.2484.

  PMID: 9466800 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1093/jn/128.11.1933.

  PMID: 9808645 BACKGROUND

• Rock CL. Nutritional factors in cancer prevention. Hematol Oncol Clin North Am. 1998 Oct;12(5):975-91. doi: 10.1016/s0889-8588(05)70037-x.

  PMID: 9888017 BACKGROUND

• Rock CL. Dietary Reference Intakes, antioxidants, and beta carotene. J Am Diet Assoc. 1998 Dec;98(12):1410-1. doi: 10.1016/S0002-8223(98)00317-4. No abstract available.

  PMID: 9850107 BACKGROUND

• Rock CL. Carotenoids: biology and treatment. Pharmacol Ther. 1997 Sep;75(3):185-97. doi: 10.1016/s0163-7258(97)00054-5.

  PMID: 9504139 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cheryl L. Rock, PhD, RD

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 27, 2004
• Study Start: October 1, 1997
• Last Updated: May 20, 2014

Record last verified: 2007-08

Locations

US (1)