BRCA1 Gene MutationNCT02197000
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
A study testing DIM-Avail 100mg in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- What is being tested?
- DIM-Avail 100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Nov 2014to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
Read the detailed description
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.
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Being tested
- DIM-Avail 100mg
- Keywords
- BRCA mutation, Breast cancer, Estrogen metabolism, 3,3-Diindolylmethane, Breast density
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIM-Avail 100mgDietary supplement
Also called 3,3-Diindolylmethane
DIM 100 mg*1 daily for 2 years
| Study group | Role | What they receive |
|---|---|---|
| DIM-Avail 100mg | Experimental | women will receive DIM 100mg*1/d, a nutritional supplement for 24 months. Receives: Dietary Supplement: DIM-Avail 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in breast density compared to baseline
The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI)
Measured: 0, 12 and 24 months following intiation
Secondary outcomes (3)
Estrogen profile
changes in TSH (Thyroid Stimulating Hormone), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Estrogen, Prolactin, Progesterone and Testosterone compare to baseline
Measured: 0, 4, 8, 12, 16 and 24 months following initiation
The Estronex Profile
changes in the 2, 4, and 16 alpha- hydroxyderivative of estrone and the 2 and 4 methoxyestrone compare to baseline
Measured: 0, 12 and 24 months following initiation
change in Quality of life
Quality of life will be evaluate using the Revised Illness Perception Questionnaire.
Measured: 0, 4, 8, 12, 16 and 24 months following initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start11 Nov 2014
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD, PhD, Principal investigator, Rabin Medical Center, Beilinson campus, Petah-Tikva, IsraelRinat Yerushalmi, MD, Principal investigator, Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197000
- Sponsor's protocol ID
- 0117-14-RMC
- Status last verified
- Oct 2017
- First submitted
- 20 Jul 2014
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02197000
- Acronym / sponsor ID
- 0117-14-RMC
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Keywords
- BRCA mutation, Breast cancer, Estrogen metabolism, 3,3-Diindolylmethane, Breast density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIM-Avail 100mg | Experimental | Dietary Supplement: DIM-Avail 100mgwomen will receive DIM 100mg*1/d, a nutritional supplement for 24 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIM-Avail 100mgAlso: 3,3-DiindolylmethaneDIM 100 mg*1 daily for 2 years | Dietary supplement | DIM-Avail 100mg |
Primary outcome
Changes in breast density compared to baseline
Time frame: 0, 12 and 24 months following intiation
The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI)
3 secondary outcomes
Estrogen profile
Time frame: 0, 4, 8, 12, 16 and 24 months following initiation
The Estronex Profile
Time frame: 0, 12 and 24 months following initiation
change in Quality of life
Time frame: 0, 4, 8, 12, 16 and 24 months following initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Margel, MD, PhD principal investigator
Rabin Medical Center, Beilinson campus, Petah-Tikva, Israel
Rinat Yerushalmi, MD principal investigator
Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIM-Avail 100mg in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in breast density compared to baseline (time frame: 0, 12 and 24 months following intiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.