Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
1997-10-31
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia.
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Detailed Description
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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.
Conditions
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Study Design
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PREVENTION
Interventions
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preventative dietary intervention
Eligibility Criteria
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Inclusion Criteria
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
18 Years
55 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Diego
OTHER
Principal Investigators
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Cheryl L. Rock, PhD, RD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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University of California San Diego Cancer Center
La Jolla, California, United States
Countries
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References
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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.
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.
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. doi: 10.1093/jn/128.11.1933.
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.
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.
Rock CL. Carotenoids: biology and treatment. Pharmacol Ther. 1997 Sep;75(3):185-97. doi: 10.1016/s0163-7258(97)00054-5.
Other Identifiers
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CDR0000065806
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-P97-0100
Identifier Type: -
Identifier Source: secondary_id
UCSD-960928
Identifier Type: -
Identifier Source: org_study_id
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