Plant-Based Nutrition for Breast or Endometrial Cancer

NCT07189702 | Not Yet Recruiting

• 1 other identifier: STUDY00010949
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer Metastatic; Endometrial Cancer Stage IV

Keywords

Metastatic; Metastatic Breast; Metastatic Endometrial; Breast Stage IV; Endometrial Stage IV; Nutrition; Plant-Based Nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Mean Change in Disease-Specific Quality of Life - FACT-B at 13 and 26 Weeks

  13 weeks, 26 weeks

• Mean Change in Disease-Specific Quality of Life - FACT-En at 13 and 26 Weeks

  13 weeks, 26 weeks

• Mean Change in Cognitive Dysfunction (FACT-COG) at 13 and 26 Weeks

  13 weeks, 26 weeks

• Mean Change in Cancer-Related Fatigue (BFI) at 13 and 26 Weeks

  13 weeks, 26 weeks

• Mean Change in General Symptoms (MDASI) at 13 and 26 Week

  13 weeks, 26 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Regular Diet with Cancer-Related Wellness Education and Support

Other: Control

Whole Food, Plant-Based Diet with Behavioral 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

Interventions

Control OTHER

Regular Diet with Cancer-Related Wellness Education and Support

Control

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasm Metastasis

Interventions

Diet, Plant-Based; Palliative Care

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Thomas M Campbell, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Erin K Campbell, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M Blanchard, BS

CONTACT

585-953-6709; lisa_blanchard@urmc.rochester.edu

Erin k Campbell, MD,MPH

CONTACT

585-602-0477; Erin_Campbell@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Part-Time) - Department of Family Medicine (SMD)

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 24, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share