Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Breast Cancer Personalized Nutrition Study (BREACPNT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079270
Recruitment Status : Recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Dr. Einav NiliGal-Yam, Sheba Medical Center

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 and various biomarkers in hormone receptor early breast cancer patients receiving adjuvant endocrine treatment.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Nutrition intervention Not Applicable

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 several studies. Hence, weight management for breast cancer survivors is important for increasing adherence to therapy and lowering recurrence risk.

The essential role of the gut microbiota in modulating immune and metabolic functions in health and disease is increasingly recognized. Particularly in breast cancer (BC), diet plays an important role in creating a microbiome environment involved in estrogens metabolism. The microbiome directly affects the body's response to food.

The Personalized Nutrition Project, conducted in the Weizmann Institute of Science, showed that individuals vary greatly in their glycemic response to the same food, influenced by the involvement of functional microbial pathways. This study yielded an algorithm capable of accurately predicting personalized postprandial glycemic response (PPGR) to arbitrary meals. These results suggest that individually tailored dietary interventions help maintain normal blood glucose levels and influence microbiome diversity, which, in turn, can control weight changes.

In this phase 2 randomized trial, 200 Hormone receptor (HR) positive breast cancer patients, eligible for adjuvant endocrine therapy will be recruited to the study. Upon recruitment, subjects will provide a stool sample for microbiome analysis and will undergo continuous glucose monitoring for 2 weeks. Thereafter, patients will be randomly assigned in a 1:1 ratio to receive a personalized diet recommendation or a standard low-fat diet for 6 months. The algorithm is based on patients' microbiome analyses and other blood tests. Patient clinical records will be followed 2-3 times yearly for 5 years for DFS and BC recurrence.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Personalized algorithm-based diet
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.
Other: Nutrition intervention
The diet recommendations will be provided by a certified dietitian. Participants will be asked to document their food intake and daily activities including exercise and sleep using a dedicated smartphone app throughout the intervention period.

Active Comparator: standard Mediterranean low-fat diet
The control arm will receive nutritional recommendations according to the standard Israeli dietary approach Mediterranean-style low-fat diet.
Other: Nutrition intervention
The diet recommendations will be provided by a certified dietitian. Participants will be asked to document their food intake and daily activities including exercise and sleep using a dedicated smartphone app throughout the intervention period.




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months intervention period. ]
    Body weight changes will be defined as the net body weight gained/lost


Secondary Outcome Measures :
  1. To evaluate the efficacy of the personalized diet compared to a standard low fat diet to control glycemic response. [ Time Frame: 6 months intervention period. ]
    glycemic response control measured by the area under the glucose curve (AUC) during continuous glucose monitoring (CGM) period.


Other Outcome Measures:
  1. Evaluate disease outcome as measured by disease free survival in study subjects. [ Time Frame: 5 years ]
    Disease free survival (DFS), years

  2. To investigate microbiome composition and modulation during the diet intervention period and assess if there are differences in modulations between the personalized diets as compared to the standard diet [ Time Frame: 6 months intervention period. ]
    changes in microbiome compositions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079270


Contacts
Layout table for location contacts
Contact: Gal-Yam, MD 972-3-5302988 Einav.NiliGal-Yam@sheba.health.gov.il

Locations
Layout table for location information
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Gal-Yam    972-3-5302988      
Principal Investigator: Einav Gal-Yam, MD         
Sub-Investigator: Eran Segal, PhD         
Sponsors and Collaborators
Sheba Medical Center
Weizmann Institute of Science
Investigators
Layout table for investigator information
Principal Investigator: Gal-Yam, MD Sheba Medical Center

Publications:
Layout table for additonal information
Responsible Party: Dr. Einav NiliGal-Yam, Deputy Head, Breast Cancer Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04079270     History of Changes
Other Study ID Numbers: SMC- 5725-18
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request .
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 12 months after publication
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Einav NiliGal-Yam, Sheba Medical Center:
Weight gain
Endocrine treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases