Plant-Based Nutrition for Breast or Endometrial Cancer (BEND-MBEC)

A Randomized Controlled Trial of Behavioral Education and Nutrition Delivery in Women With Metastatic Breast and Endometrial Cancer. (The BEND-MBEC Study)

This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Metastatic; Endometrial Cancer Stage IV
• Intervention / Treatment: Other: Control; Other: Whole Food, Plant-Based Diet with Behavioral Education and Support

Detailed Description

This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer. It is designed to explore whether this dietary intervention is sustainable in this population for 26 weeks and whether improvements in quality of life and cardiometabolic health demonstrated in a previous study are sustained. If so, this study will gather information to know whether these benefits translate into reduced overall mortality and cancer markers when compared with a control group that is matched for time and attention but does not implement dietary change. The intervention consists of a whole food plant-based dietary program, group education and individual coaching/visits while the control group gets general wellness group education and individual visits while maintaining their usual diet.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa M Blanchard, BS; Phone Number: 585-953-6709; Email: lisa_blanchard@urmc.rochester.edu
• Study Contact Backup: Name: Erin k Campbell, MD,MPH; Phone Number: 585-602-0477; Email: Erin_Campbell@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: • Female sex (as assigned at birth), aged 18 years or older

• A confirmed diagnosis of endometrial or metastatic breast cancer. All subtypes are eligible
• Treating oncologist approval and expected survival of at least six months
• Undergoing any systemic treatment including hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have active cancer and have been recommended but declined systemic treatment are also eligible.
• Willing to adopt a strict, whole-foods, plant-based diet
• Willing and able to comply with the WFPB protocol for the duration of the study including scheduled testing, Zoom meetings, and office visits
• Able to speak and read English fluently.
• Women with plans for radiation therapy or surgery are also eligible provided that they meet all other eligibility criteria.

Exclusion Criteria: • BMI ≤ 20.0 kg/m2

• Inability to tolerate a normal diet
• Active malabsorption syndrome at time of consent, as determined by study physicians (i.e. Crohn's disease, bowel surgery)
• Any food allergies or intolerances that would interfere with study compliance
• Recent consumption (in the past six months) of a vegan diet
• eGFR < 30 on ≥ two lab tests in the past six months
• Serum potassium > 5.4 in the past six months
• Current insulin or sulfonylurea use
• Current warfarin use (non-vitamin K antagonist allowed)
• High-risk alcohol use (>7 drinks/wk)
• Illicit substance use (not including marijuana)
• Cognitive impairment or psychiatric disorder impairing ability to give consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Regular Diet with Cancer-Related Wellness Education and Support	Other: Control; Regular Diet with Cancer-Related Wellness Education and Support
Experimental: Whole Food, Plant-Based Diet with Behavioral Education and Support	Other: Whole Food, Plant-Based Diet with Behavioral Education and Support; Whole Food, Plant-Based Diet with Behavioral Education and Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Dietary Adherence at 13 and 26 Weeks	Dietary adherence is assessed by study personnel using pre-specified criteria. Participants are considered "adherent" if ≥80% of total calories are consumed from 'on-plan' foods. A single adherence score is calculated as the percentage of calories consumed from on-plan foods, averaged over the assessment period. Higher scores indicate greater adherence.	13 weeks, 26 weeks
Mean Change in Participant Retention at 13 and 26 Weeks	Retention is calculated as the percentage of consented participants who provide both baseline and post-intervention assessments. Higher percentages indicate better retention in the WFPB dietary intervention.	13 weeks, 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Disease-Specific Quality of Life - FACT-B at 13 and 26 Weeks	Quality of life is assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. Individual item scores are summed to create subscale scores and a total score, with higher scores indicating better quality of life. Mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Disease-Specific Quality of Life - FACT-En at 13 and 26 Weeks	Quality of life is assessed using the Functional Assessment of Cancer Therapy - Endocrine (FACT-En) questionnaire. Item responses are summed for subscales and a total score, with higher scores indicating better QOL. Mean change from baseline is evaluated.	13 weeks, 26 weeks
Mean Change in Cognitive Dysfunction (FACT-COG) at 13 and 26 Weeks	Cognitive function is measured using the FACT-COG questionnaire. Items are summed to generate a total cognitive dysfunction score. Higher scores indicate greater cognitive function (less dysfunction). Mean change from baseline is calculated to assess improvement or decline.	13 weeks, 26 weeks
Mean Change in Cancer-Related Fatigue (BFI) at 13 and 26 Weeks	Fatigue is assessed using the Brief Fatigue Inventory (BFI). Scores for each item range from 0 (no fatigue) to 10 (severe fatigue) and are averaged to obtain a total fatigue score. Lower scores indicate less fatigue. Mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in General Symptoms (MDASI) at 13 and 26 Week	General symptoms are measured using the MD Anderson Symptom Inventory (MDASI). Items are rated 0-10, with higher scores indicating greater symptom severity. Total symptom burden is calculated by summing items. Mean change from baseline is evaluated to assess improvement.	13 weeks, 26 weeks
Overall Survival at Close of Study	Overall survival is defined as the time from study enrollment to death from any cause. Survival status is determined through medical records and follow-up.	End of study (26 weeks)
Mean Change in Cardiometabolic Marker (Weight) at 13 and 26 Weeks	Weight is collected at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Lipids) at 13 and 26 Weeks	Lipids are measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Blood Pressure) at 13 and 26 Weeks	Blood Pressure is measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Insulin) at 13 and 26 Weeks	Insulin is measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Inflammation) at 13 and 26 Weeks	Inflammation is measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Blood Glucose) at 13 and 26 Weeks Description:	Blood Glucose is measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Hormonal Marker (IGF1) at 13 and 26 Weeks	Description: IGF1 is measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks
Mean Change in Hormonal Marker (sex hormones) at 13 and 26 Weeks	Sex hormones are measured at each time point, and mean change from baseline is calculated.	13 weeks, 26 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Thomas M Campbell, MD, University of Rochester; Principal Investigator: Erin K Campbell, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: September 12, 2025
• First Submitted That Met QC Criteria: September 15, 2025
• First Posted (Actual): September 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition; Metastatic; Metastatic Breast; Metastatic Endometrial; Breast Stage IV; Endometrial Stage IV; Plant-Based Nutrition
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Neoplastic Processes; Genital Neoplasms, Female; Uterine Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Endometrial Neoplasms; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Patient Care; Health Services; Health Care Facilities Workforce and Services; Diet Therapy; Nutrition Therapy; Diet; Palliative Care; Diet, Plant-Based
• Other Study ID Numbers: STUDY00010949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No