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The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
The Research Question: In female BRCA mutation carriers, will adding DIM (100mg*1/d, a nutritional supplement), decrease breast density in two years?
Study design: A single center single arm prospective interventional study of the use of DIM to decrease risk of breast cancer among female BRCA carriers.
Study population: Subjects will be female carriers of a BRCA mutation and have more than 10% mammographic breast density at baseline.
Intervention: DIM supplement (100mg*1/d).
Study 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.
Primary Endpoint: A decrease of more than 10% in breast density compared to baseline, following DIM supplementation intervention among female BRCA carriers.
Study 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIM-Avail 100mg | Experimental | women will receive DIM 100mg*1/d, a nutritional supplement for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIM-Avail 100mg | Dietary Supplement | DIM 100 mg*1 daily for 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in breast density compared to baseline | The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI) | 0, 12 and 24 months following intiation |
| Measure | Description | Time Frame |
|---|---|---|
| Estrogen profile | changes in TSH (Thyroid Stimulating Hormone), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Estrogen, Prolactin, Progesterone and Testosterone compare to baseline | 0, 4, 8, 12, 16 and 24 months following initiation |
| The Estronex Profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Margel, MD, PhD | Rabin Medical Center, Beilinson campus, Petah-Tikva, Israel | Principal Investigator |
| Rinat Yerushalmi, MD | Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C016392 | 3,3'-diindolylmethane |
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changes in the 2, 4, and 16 alpha- hydroxyderivative of estrone and the 2 and 4 methoxyestrone compare to baseline |
| 0, 12 and 24 months following initiation |
| change in Quality of life | Quality of life will be evaluate using the Revised Illness Perception Questionnaire. | 0, 4, 8, 12, 16 and 24 months following initiation |
| D017437 |
| Skin and Connective Tissue Diseases |