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Lifestyle Changes for Breast Cancer Risk Reduction

N/A
Recruiting
Led By Karen M Basen-Engquist
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to walk without an assistive device
No history of renal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Summary

This trial looks at how well a lifestyle intervention can reduce the risk of breast cancer in normal weight women by changing their body composition and decreasing inflammation.

Who is the study for?
This trial is for postmenopausal women who are of normal weight with a BMI between 18.5 and <25, have excess body fat, no history of invasive cancer except non-melanoma skin cancer, no major surgery within the last 3 months, can exercise safely, and work at MD Anderson Cancer Center but not directly under the study's principal investigator.
What is being tested?
The trial tests if lifestyle changes like diet control and physical activities (resistance training and aerobic exercises) can reduce breast cancer risk by decreasing body fat and inflammation in normal-weight women with high breast cancer risk due to excess body fat.
What are the potential side effects?
Since this intervention involves dietary changes and exercise programs rather than medication or medical procedures, side effects may include muscle soreness from exercise or discomfort from dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk on my own without needing help from devices.
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I have never had kidney disease.
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My BMI is between 18.5 and 25.
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I have never had cancer, except for non-melanoma skin cancer.
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My DXA scan shows I have a trunk fat mass of 9.4 kg or more.
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I am a postmenopausal woman.
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My BMI is between 18.5 and 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (lifestyle intervention)Experimental Treatment5 Interventions
Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.
Group II: Group II (wait-list, lifestyle intervention)Active Control5 Interventions
Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,651 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,950 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Foundation for Women's CancersUNKNOWN
~6 spots leftby Apr 2025
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