Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer (NCT02494869) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer
United States75 participantsStarted 2015-07
Plain-language summary
This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue.
The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
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.
Inclusion Criteria:
* Women at high-risk of breast cancer as defined by one of the following:
* Cytologically confirmed atypical hyperplasia
* Cytologically confirmed LCIS
* Being a carrier for
* BRCA1 and/or BRCA2
* Predicted lifetime risk of breast cancer \>20% based on family history)
* Predicted 10-year risk of breast cancer of ≥ 2.31%
* Predicted 5-year risk of breast cancer ≥ 1.67%
* Aged 21 ≤ 80 years old
* If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
* Women \<50 years old who are of child-bearing potential must have a negative pregnancy test (urine HCG or serum) within 14 days of enrollment.
* Must a negative mammogram or negative breast MRI within 1 year of protocol required baseline core biopsy
* Clinical breast exam interpreted as benign (not suspicious for cancer) at MSK
* Performing less than or equal to 120 minutes of structured moderate-intensity or strenuous-intensity exercise per week
* Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
* Able to achieve an acceptable peek baseline CPET defined as by any of the following criteria:
* achieving a plateau in oxygen consumption concurrent an with increase in power output;
* a respiratory exchange ratio ≥ 1.10;
* attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted \[HRmax =…
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 studying women at high risk for breast cancer — how would you determine whether I actually fall into that high-risk category, and would that assessment be useful for my care regardless of whether I join this study?
2The trial is looking at how different amounts of aerobic exercise change gene expression in breast tissue cells — does the current evidence suggest that exercise intensity or frequency actually matters for reducing breast cancer risk in high-risk women, or is that still an open question?
3Since this study is 'active not recruiting,' I can't join it — but are there similar exercise-based or lifestyle intervention trials I could look into, or would you recommend I just follow an exercise plan based on what's already known?
4The trial measures changes in breast epithelial cell gene expression, which involves collecting breast tissue samples — if I were considering a similar study in the future, what would that kind of biopsy or sampling process actually involve for me?
5Given that this is a Phase N/A study focused on measuring biological changes rather than testing a treatment, how should I think about whether exercise changes my actual breast cancer risk right now, and is there anything I should be doing differently based on what research already shows?
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
gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer