Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT07189702
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07189702
Study Brief:
Protocol Section:
NCT07189702