Personalized nutrition intervention for breast cancer patients
A Phase 2 Single-blinded Randomized Study of Algorithm-based Personalized Nutrition Intervention Compared to Standard Diet Intervention in Patients Treated With Endocrine Therapy for Early Stage, Hormone Receptor Positive Breast Cancer
NA · Sheba Medical Center · NCT04079270
This study is testing if a personalized diet based on gut health can help women with hormone receptor-positive breast cancer manage weight gain and improve their overall health while they are on treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sheba Medical Center (other gov) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT04079270 on ClinicalTrials.gov |
What this trial studies
The Breast Cancer Personalized Nutrition study evaluates how a microbiome-based personalized diet can help manage weight gain and improve health outcomes in hormone receptor-positive breast cancer patients undergoing adjuvant endocrine treatment. The study recognizes that weight gain is a common issue for breast cancer survivors, particularly those on endocrine therapy, and aims to tailor dietary interventions based on individual microbiome analysis. By analyzing stool samples and using algorithms to predict glycemic responses, the study seeks to create personalized dietary plans that may enhance treatment adherence and reduce recurrence risk.
Who should consider this trial
Good fit: Ideal candidates are hormone receptor-positive breast cancer patients who have completed surgery and are currently receiving adjuvant endocrine therapy.
Not a fit: Patients who are currently on oral antibiotics or antifungals may not benefit from this study due to potential interference with microbiome analysis.
Why it matters
Potential benefit: If successful, this study could provide a personalized dietary approach that helps breast cancer patients manage weight gain and improve their overall health during treatment.
How similar studies have performed: Other studies have shown promising results with personalized nutrition approaches, particularly in managing metabolic responses in cancer patients, suggesting this study builds on established concepts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Ramat Gan
- Sheba Medical Center — Ramat Gan, Israel (RECRUITING)
Study contacts
- Principal investigator: Gal-Yam, MD — Sheba Medical Center
- Study coordinator: Gal-Yam, MD
- Email: Einav.NiliGal-Yam@sheba.health.gov.il
- Phone: 972-3-5302988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Weight gain, Endocrine treatment