Status:
UNKNOWN
The Breast Cancer Personalized Nutrition Study
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Weizmann Institute of Science
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The Breast Cancer Personalized Nutrition (BREACPNT) study will evaluate the effect of a microbiome based personalized diet intervention on control of weight gain, glycemic response, disease outcome an...
Detailed Description
Weight gain is a common incident in breast cancer survivors. As many as 50-96% of women experience weight gain during treatment. Endocrine treatment was identified as a risk factor for weight gain in ...
Eligibility Criteria
Inclusion
- Patients diagnosed with stage 1-3 breast cancer, who underwent surgery, have finished their neo/adjuvant chemotherapy and radiotherapy if these were indicated and are treated with adjuvant endocrine therapy (either Tamoxifen or Aromatase inhibitor +/- GNRH agonists).
- Patients are at least 60 days after finishing their last non-endocrine oncology treatment (i.e. definitive surgery, radiation or chemotherapy - whichever is last), have received at least 30 days of endocrine therapy ( tamoxifen or aromatase inhibitor) but no more than 24 months.
- Patients treated with neoadjuvant endocrine therapy are eligible provided they had undergone surgery, are least 60 days post their last non endocrine therapy (definitive surgery or radiation and chemotherapy, if these were indicated), are continuing their endocrine therapy but did not receive more than 24 months post-surgery.
- Are willing to work with smart phone application
Exclusion
- Oral Antibiotics/antifungal use in the previous 3 months to profiling stage ( these patients will be able to join the study at a later point)
- Use of anti-diabetic and/or weight-loss medication
- BMI\<18.5
- People under another diet regime and/or a dietitian consultation/another study?
- Pregnancy, breast feeding
- HIV carriers, Cushing syndrome, Chronic Kidney Disease, acromegaly, hyperthyroidism, liver cirrhosis
- Psychiatric disorders (Schizophrenia, Bipolar Disorder)
- Known diagnosis of IBD (inflammatory bowel diseases)
- Patients that underwent Bariatric surgery
- Known Alcohol or substance abuse
- Known Diagnosis of diabetes
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04079270
Start Date
July 17 2019
End Date
December 1 2025
Last Update
September 6 2019
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel