A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Wo… (NCT04298086) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
United States43 participantsStarted 2020-03-04
Plain-language summary
The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Acute myocardial infarction within 3-5 days of any planned study procedures;
. Unstable angina
. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
. Recurrent syncope
. Active endocarditis
. Acute myocarditis or pericarditis
. Symptomatic severe aortic stenosis
. Uncontrolled heart failure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for overweight postmenopausal women with hormone receptor-positive breast cancer — given my personal diagnosis and health profile, is this a population that even applies to me, and would my doctor consider my situation a good or poor fit?
2The trial is measuring changes in breast aromatase levels as its main outcome — can my doctor explain what aromatase is, why it matters for hormone receptor-positive breast cancer, and what it would mean for my treatment if my aromatase levels did or didn't change?
3Since this is a Phase 2 trial, what does that mean in terms of how much is already known about whether this exercise and plant-based diet combination is safe and beneficial, compared to just following standard treatment recommendations on my own?
4The trial is active but no longer recruiting new participants — does my doctor know of any similar ongoing studies I might still be eligible for, or any findings from this kind of lifestyle-focused research that could already inform my care plan?
5How demanding would committing to both a structured exercise program and a plant-based diet be during breast cancer treatment, and is my doctor concerned that attempting both at once could be too much given my current health and treatment schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.