Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT00100893
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2005-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511402', 'term': 'Grape Seed Proanthocyanidins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2005-01-06', 'studyFirstSubmitQcDate': '2005-01-06', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin', 'timeFrame': 'at 1, 2, 4, 8, and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)', 'timeFrame': 'at 1, 2, 4, 8, and 12 weeks'}, {'measure': 'Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides', 'timeFrame': 'at 12 weeks'}, {'measure': 'Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides', 'timeFrame': 'at 12 weeks'}, {'measure': 'Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)', 'timeFrame': 'at 12 weeks'}, {'measure': 'Pharmacokinetics as measured by procyanidins', 'timeFrame': 'before and after first dose and then at 1, 2, 4, 8, and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer.\n* Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants.\n* Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants.\n* Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants.\n\nOUTLINE: This is a pilot, dose-finding, placebo-controlled study.\n\nParticipants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity.\n\nCohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose.\n\nPROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* At risk of developing breast cancer\n* No history of breast cancer or ductal carcinoma in situ\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 40 to 75\n\nSex\n\n* Female\n\nMenopausal status\n\n* Postmenopausal, defined by 1 of the following criteria:\n\n * No spontaneous menses for ≥ 12 months\n * Prior bilateral oophorectomy\n * Prior hysterectomy with follicle-stimulating hormone within menopausal range\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Hemoglobin ≥ 9.0 g/dL\n* Platelet count ≥ 100,000/mm\\^3\n* WBC ≥ 3,500/mm\\^3\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* No coagulation disorders\n\nHepatic\n\n* SGOT and SGPT ≤ 2 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No major illness of the cardiovascular system\n\nPulmonary\n\n* No major illness of the respiratory system\n\nOther\n\n* No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer\n* No major systemic infection\n* No Cushing's syndrome or adrenal insufficiency\n* No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol \\[vitamin D\\] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* More than 3 months since prior hormone-modifying medications, including any of the following:\n\n * Oral contraceptives\n * Hormone replacement therapy\n * Selective estrogen receptor modifiers\n * Aromatase inhibitors\n * Gonadotropin-releasing hormone modifiers\n* Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* No red wine, red grapes, or white button mushrooms directly before or during study treatment\n\n * White and seedless grapes allowed\n* No other concurrent therapy"}, 'identificationModule': {'nctId': 'NCT00100893', 'briefTitle': 'IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer', 'orgStudyIdInfo': {'id': '03178'}, 'secondaryIdInfos': [{'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CHNMC-IRB-03178'}, {'id': 'CDR0000407637', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement: grape seed proanthocyanidin extract', 'description': 'Administered orally.', 'interventionNames': ['Dietary Supplement: IH636 grape seed proanthocyanidin extract']}], 'interventions': [{'name': 'IH636 grape seed proanthocyanidin extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage', 'armGroupLabels': ['Dietary Supplement: grape seed proanthocyanidin extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}