Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women (NCT04267796) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women
United States40 participantsStarted 2021-06-25
Plain-language summary
This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.
Who can participate
Age range
50 Years – 69 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.
Inclusion Criteria:
* Age 50-69 years old
* Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy)
* Self-reported height and weight indicating a BMI \>= 18.5 and \< 25 kg/m\^2
* No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)
* No history of invasive cancer, other than non-melanoma skin cancer
* No history of renal disease
* Able to walk without an assistive device
* Not within 3 months of major surgery
* Able to speak/read/write in English
* Has internet access on a computer or mobile device
* A trunk fat mass \>= 9.4 kg as indicated by a dual x-ray absorptiometry (DXA) scan
* Height and weight indicating a BMI of \>= 18.5 and \< 25 kg/m\^2 verified at the screening visit
Exclusion Criteria:
* MD Anderson employees that report to the principal investigator of this study
* Participants that cannot engage in the exercise program for more than three weeks during the study period
* Participants that are currently doing strength exercises that work all major muscle groups (defined as: participants who complete more than 16 repetitions per exercise in their current resistance training regimen, or who don't find their last 1-2 reps to be difficult in their current regimen, or who increase the weight in their current routine).
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.