Lifestyle changes to reduce breast cancer risk in normal weight women
Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women
This study is testing whether a diet and exercise program can help normal weight postmenopausal women with high body fat lower their risk of breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04267796 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a lifestyle intervention aimed at reducing breast cancer risk in postmenopausal women who are of normal weight but have high body fat. Participants will be randomized into two groups, one receiving a structured diet and exercise program over 16 weeks, while the other serves as a control. The study will assess changes in body composition, inflammation markers, and overall health-related quality of life. The goal is to determine if these lifestyle changes can effectively lower breast cancer risk.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50-69 with a normal BMI but elevated trunk fat mass.
Not a fit: Patients with a history of invasive cancer or significant health issues that contraindicate exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of breast cancer in at-risk women through lifestyle modifications.
How similar studies have performed: Other studies have shown promise in lifestyle interventions for cancer risk reduction, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Karen M Basen-Engquist — M.D. Anderson Cancer Center
- Study coordinator: Karen M. Basen-Engquist
- Email: kbasenen@mdanderson.org
- Phone: 713-745-3123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.