Clinical trial · Interventional
The Breast Cancer Personalized Nutrition Study
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
NCT04079270CI-TRIAL-00040426BREACPNTunknownN/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 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 and various biomarkers in hormone receptor early breast cancer patients receiving adjuvant endocrine treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutrition intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Personalized algorithm-based diet
- description
- The intervention arm will be an 'algorithm-based' arm in which patients will receive personally tailored dietary recommendations, based on their microbiome, and other clinical data such as blood tests and lifestyle features.
- interventionNames
- Other: Nutrition intervention
- type
- ACTIVE_COMPARATOR
- label
- standard Mediterranean low-fat diet
- description
- The control arm will receive nutritional recommendations according to the standard Israeli dietary approach Mediterranean-style low-fat diet.
- interventionNames
- Other: Nutrition intervention
Primary outcomes (1)
- measure
- To evaluate the efficacy of a personalized diet compared to a standard low fat diet to control body mass as measured by changes in body mass.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDZeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. PMID 26590418
- BACKGROUNDNyrop KA, Williams GR, Muss HB, Shachar SS. Weight gain during adjuvant endocrine treatment for early-stage breast cancer: What is the evidence? Breast Cancer Res Treat. 2016 Jul;158(2):203-17. doi: 10.1007/s10549-016-3874-0. Epub 2016 Jun 24. PMID 27342454
- DERIVEDRein MS, Dadiani M, Godneva A, Bakalenik-Gavry M, Morzaev-Sulzbach D, Vachnish Y, Kolobkov D, Lotan-Pompan M, Weinberger A, Segal E, Gal-Yam EN. BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy - a protocol for a randomised clinical trial. BMJ Open. 2022 Nov 21;12(11):e062498. doi: 10.1136/bmjopen-2022-062498. PMID 36410828