Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer (NCT00892515) | Clinical Trial Compass
CompletedNot Applicable
Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer
United States183 participantsStarted 2008-10
Plain-language summary
RATIONALE: Exercise may change the risk of developing breast cancer. It is not yet known whether low-intensity exercise or high-intensity exercise is more effective in lowering the risk of breast cancer.
PURPOSE: This randomized clinical trial is studying how well exercise programs work in healthy young women at increased risk of developing breast cancer.
Who can participate
Age range
18 Years – 35 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.
DISEASE CHARACTERISTICS:
* Healthy women with ≥ 18% lifetime risk for breast cancer as evidenced by the following:
* Documentation from a genetic counselor of a known familial breast cancer susceptibility mutation
* Claus model risk of ≥18%
* Predicted probability of BRCA1/2 mutation \> 25% based on the Myriad model
* Documentation of a known mutation in a family member such that the Mendelian probability of a BRCA1/2 mutation would be \>25%
* History of lobular carcinoma in situ
* No prior prophylactic mastectomy
* Leisure-time exercise energy expenditure of ≤ 500 kcal/week over the past 6 months
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Premenopausal
* Menstrual cycles 25-32 days in length
* Intact ovaries and uterus
* Gynecologic age (defined as participant's current age minus the age at which she started menstruating) of at least 4 years
* Body mass index 21-50
* No history of menstrual difficulties
* No history of physician-diagnosed gynecological disease (e.g., fibroids, endometriosis, or polycystic ovary syndrome)
* Not pregnant
* Not planning to become pregnant during the study period
* No medical conditions or medications that would prohibit participation in aerobic exercise or would negatively impact the study
* No history of cancer, except nonmelanoma skin cancers, and in situ cervical cancers
* No eating disorders (e.g., bulimia or binge-eating disorder)
* At least one year since prior smoking
* Not planning to move away from…
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.
What they're measuring
1
Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length