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

University of Rochester

Status: Not yet enrolling

Conditions: Endometrial Cancer Stage IV; Breast Cancer Metastatic

Treatments: Other: Whole Food, Plant-Based Diet with Behavioral Education and Support; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07189702

STUDY00010949

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

Active Comparator group

Description:

Regular Diet with Cancer-Related Wellness Education and Support

Treatment:

Other: Control

Whole Food, Plant-Based Diet with Behavioral Education and Support

Experimental group

Description:

Whole Food, Plant-Based Diet with Behavioral Education and Support

Treatment:

Other: Whole Food, Plant-Based Diet with Behavioral Education and Support