Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT00003094
Status:
WITHDRAWN
Last Update Posted:
2014-05-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotenoid Rich Diet in Treating Cervical Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was halted prematurely, prior to enrollment of first participant', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-26', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cervical cancer'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '10789491', 'type': 'BACKGROUND', 'citation': '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': '9466800', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9808645', 'type': 'BACKGROUND', 'citation': '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': '9888017', 'type': 'BACKGROUND', 'citation': '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': '9850107', 'type': 'BACKGROUND', 'citation': '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': '9504139', 'type': 'BACKGROUND', 'citation': 'Rock CL. Carotenoids: biology and treatment. Pharmacol Ther. 1997 Sep;75(3):185-97. doi: 10.1016/s0163-7258(97)00054-5.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: A diet rich in carotenoids may be an effective treatment for cervical dysplasia.\n\nPURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia.', 'detailedDescription': '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).\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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\n\nPATIENT 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\n\nPRIOR 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'}, 'identificationModule': {'nctId': 'NCT00003094', 'briefTitle': 'Carotenoid Rich Diet in Treating Cervical Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Carotenoid-Rich Diet Trial to Reverse CIN II', 'orgStudyIdInfo': {'id': 'UCSD-960928'}, 'secondaryIdInfos': [{'id': 'CDR0000065806', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-P97-0100'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'preventative dietary intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Cheryl L. Rock, PhD, RD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}