Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-27 @ 12:47 AM
Study NCT ID:
NCT02197000
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2014-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
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': 'C016392', 'term': "3,3'-diindolylmethane"}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2014-07-20', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in breast density compared to baseline', 'timeFrame': '0, 12 and 24 months following intiation', 'description': 'The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI)'}], 'secondaryOutcomes': [{'measure': 'Estrogen profile', 'timeFrame': '0, 4, 8, 12, 16 and 24 months following initiation', 'description': 'changes in TSH (Thyroid Stimulating Hormone), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Estrogen, Prolactin, Progesterone and Testosterone compare to baseline'}, {'measure': 'The Estronex Profile', 'timeFrame': '0, 12 and 24 months following initiation', 'description': 'changes in the 2, 4, and 16 alpha- hydroxyderivative of estrone and the 2 and 4 methoxyestrone compare to baseline'}, {'measure': 'change in Quality of life', 'timeFrame': '0, 4, 8, 12, 16 and 24 months following initiation', 'description': 'Quality of life will be evaluate using the Revised Illness Perception Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BRCA mutation', 'Breast cancer', 'Estrogen metabolism', '3,3-Diindolylmethane', 'Breast density'], 'conditions': ['BRCA1 Gene Mutation', 'BRCA2 Gene Mutation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.', 'detailedDescription': 'The Research Question: In female BRCA mutation carriers, will adding DIM (100mg\\*1/d, a nutritional supplement), decrease breast density in two years?\n\nStudy design: A single center single arm prospective interventional study of the use of DIM to decrease risk of breast cancer among female BRCA carriers.\n\nStudy population: Subjects will be female carriers of a BRCA mutation and have more than 10% mammographic breast density at baseline.\n\nIntervention: DIM supplement (100mg\\*1/d).\n\nStudy Time line: This will be a 2 years study. At initiation a breast mammography will be performed and eligibility assessed. Follow-up visits will occur every 4 months and quality of life questionnaires as well as adherence to DIM supplementation will be assessed. At the initiation and every 4 months blood and urine samples will be collected for Estrogen profile. At 12 and 24 months a mammography will be performed to verify changes in breast density.\n\nPrimary Endpoint: A decrease of more than 10% in breast density compared to baseline, following DIM supplementation intervention among female BRCA carriers.\n\nStudy impact: Decrease in mammographic breast density was shown to be a good marker for lower risk of breast cancer. This study has the potential to dramatically impact the management of female BRCA carriers. If we prove that by adding a food supplement breast density is decreased, we will change standard of care in these woman. In addition, the urine and blood samples collected during the study will be used for future translational research on the pathogenesis of breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who carrier the BRCA 1\\\\2 mutation.\n* No history of breast or ovarian malignancy.\n* i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ≤ 2.\n* Age 18-70.\n* Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.\n* Informed written consent must be signed according to ICH/EU GCP, before subject registration.\n\nExclusion Criteria:\n\n* Women who have undergone preventive breast reduction.\n* Breast imaging demonstrating a lesion suspected to be cancerous.\n* Breast feeding or Pregnancy or planning to get pregnant.\n* Known allergy to DIM and its ingredients.'}, 'identificationModule': {'nctId': 'NCT02197000', 'briefTitle': 'A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial', 'orgStudyIdInfo': {'id': '0117-14-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIM-Avail 100mg', 'description': 'women will receive DIM 100mg\\*1/d, a nutritional supplement for 24 months.', 'interventionNames': ['Dietary Supplement: DIM-Avail 100mg']}], 'interventions': [{'name': 'DIM-Avail 100mg', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['3,3-Diindolylmethane'], 'description': 'DIM 100 mg\\*1 daily for 2 years', 'armGroupLabels': ['DIM-Avail 100mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center, Beilinson Hospital', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'David Margel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center, Beilinson campus, Petah-Tikva, Israel'}, {'name': 'Rinat Yerushalmi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}