Clinical trial · Interventional
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial
NCT02197000CI-TRIAL-00048223completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Gene Mutation | — | UNRESOLVED | — |
| BRCA2 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DIM-Avail 100mg | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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)
Secondary outcomes (3)
- measure
- Estrogen profile
- timeFrame
- 0, 4, 8, 12, 16 and 24 months following initiation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women who carrier the BRCA 1\\2 mutation. * No history of breast or ovarian malignancy. * i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ≤ 2. * Age 18-70. * Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule. * Informed written consent must be signed according to ICH/EU GCP, before subject registration. Exclusion Criteria: * Women who have undergone preventive breast reduction. * Breast imaging demonstrating a lesion suspected to be cancerous. * Breast feeding or Pregnancy or planning to get pregnant. * Known allergy to DIM and its ingredients.
References
Publications (0)
Data not yet available
No reference posted for this study.