The Breast Cancer Personalized Nutrition Study

NCT04079270 | Unknown

• 1 other identifier: SMC- 5725-18
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Weight gain; Endocrine treatment

Outcome Measures

Primary Outcomes (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.

  Body weight changes will be defined as the net body weight gained/lost

  6 months intervention period.

Secondary Outcomes (1)

• To evaluate the efficacy of the personalized diet compared to a standard low fat diet to control glycemic response.

  6 months intervention period.

Other Outcomes (2)

• Evaluate disease outcome as measured by disease free survival in study subjects.

  5 years

• 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

  6 months intervention period.

Study Arms (2)

Personalized algorithm-based diet

EXPERIMENTAL

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

standard Mediterranean low-fat diet

ACTIVE COMPARATOR

The control arm will receive nutritional recommendations according to the standard Israeli dietary approach Mediterranean-style low-fat diet.

Other: Nutrition intervention

Interventions

Nutrition intervention OTHER

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.

Personalized algorithm-based diet; standard Mediterranean low-fat diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (3)

• Zeevi 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 BACKGROUND

• Nyrop 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 BACKGROUND

• Rein 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Weight Gain

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Gal-Yam, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gal-Yam, MD

CONTACT

972-3-5302988; Einav.NiliGal-Yam@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head, Breast Cancer Institute

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: September 6, 2019
• Study Start: July 17, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after publication
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents

Locations

IL (1)