Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 12:24 PM
Study NCT ID:
NCT00099008
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2004-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019833', 'term': 'Genistein'}], 'ancestors': [{'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2004-12-08', 'studyFirstSubmitQcDate': '2004-12-08', 'lastUpdatePostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of genistein on DNA and apoptosis', 'timeFrame': '112 days', 'description': 'Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'endometrial cancer'], 'conditions': ['Breast Cancer', 'Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '18446090', 'type': 'RESULT', 'citation': 'Pop EA, Fischer LM, Coan AD, Gitzinger M, Nakamura J, Zeisel SH. Effects of a high daily dose of soy isoflavones on DNA damage, apoptosis, and estrogenic outcomes in healthy postmenopausal women: a phase I clinical trial. Menopause. 2008 Jul-Aug;15(4 Pt 1):684-92. doi: 10.1097/gme.0b013e318167b8f2.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of genistein may be effective in preventing breast or endometrial cancer.\n\nPURPOSE: This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.\n* Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants.\n* Determine the effect of genistein on estrogenic effects by self-reported side effects, measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these participants.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are stratified according to their study ID numbers. Participants are randomized to 1 of 2 treatment arms.\n\n* Arm I: Participants receive oral genistein twice daily on days 1-84.\n* Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms, treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or gross noncompliance.\n\nParticipants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28 after completion of study treatment.\n\nPROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Healthy participants\n\n * Papanicolaou test (pap smear) normal within the past 13 months\n * Mammogram normal within the past 13 months\n* No history of breast cancer\n* Not at high-risk (5-year risk \\< 1.9%) for breast cancer according to NCI's Breast Cancer Risk Assessment Tool\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 45 to 70\n\nSex\n\n* Female\n\nMenopausal status\n\n* Postmenopausal\n\n * Last spontaneous menstrual bleeding \\> 12 months ago\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC ≥ 3,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 2.0 mg/dL\n* ALT and AST \\< 2 times normal\n* No significant abnormality of the liver by physical exam\n\nRenal\n\n* Creatinine \\< 2.0 mg/dL\n\nCardiovascular\n\n* No significant cardiac disease\n* No New York Heart Association class III or IV heart disease\n* No significant abnormality of the heart by physical exam\n\nPulmonary\n\n* No significant abnormality of the lung by physical exam\n\nOther\n\n* Body mass index \\< 35\n* Follicle-stimulating hormone \\> 27 mIU/mL\n* Thyroid or endocrine function test normal\n* Alcohol intake ≤ 2 drinks/day or ≤14 drinks/week\n* Not pregnant\n* No intermediate equol values (≥10 ug/L to ≤ 20 ug/L) on soy challenge\n* No history of seizures\n* No significant abnormality of the spleen or other abdominal organs by physical exam\n* No neurologic abnormality by physical exam\n* No significant metabolic abnormality on the biochemical screen\n* No history of substance abuse or addiction\n* No tobacco use\n* No diets containing \\> 20 mg of genistein/day or \\> 40 mg isoflavone/day\n* No known intolerance to soy\n* No other serious medical illness\n* No active malignancy or malignancy initially diagnosed within the past 2 years except curatively treated nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* More than 2 years since prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* More than 3 months since prior hormonal or estrogen therapy\n* More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators\n* More than 1 month since prior supplements containing phytoestrogens or that have estrogenic side effects (soy isoflavones or PC-SPECS)\n* No concurrent thyroid medication\n\n * Other concurrent endocrine medication allowed provided medication was initiated ≥ 3 months before study entry AND participant has been on a stable regimen for the past 3 months\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* No prior hysterectomy or oophorectomy\n\nOther\n\n* More than 3 months since prior antibiotics"}, 'identificationModule': {'nctId': 'NCT00099008', 'briefTitle': 'Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women', 'orgStudyIdInfo': {'id': 'UNC-GCRC-2107'}, 'secondaryIdInfos': [{'id': 'CDR0000393450', 'type': 'OTHER', 'domain': 'PDQ number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Genistein', 'interventionNames': ['Dietary Supplement: Genistein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Genistein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PTI G-2535'], 'description': 'oral Genistein twice daily on days 1-84', 'armGroupLabels': ['Arm I']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral Placebo twice daily on days 1-84', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Steven H. Zeisel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}