Status:
NOT_YET_RECRUITING
Plant-Based Nutrition for Breast or Endometrial Cancer
Lead Sponsor:
University of Rochester
Conditions:
Breast Cancer Metastatic
Endometrial Cancer Stage IV
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
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 ...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07189702
Start Date
December 1 2025
End Date
December 1 2029
Last Update
September 24 2025
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