Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women

M.D. Anderson Cancer Center1 site in 1 country40 target enrollmentStarted: June 25, 2021Last updated: August 12, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: M.D. Anderson Cancer Center
Enrollment: 40
Locations: 1
Primary Endpoint: Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of a diet and exercise intervention to decrease body fat in postmenopausal women with normal body mass index (BMI) but high body fat (trunk fat mass 9.4 kg, the 50th percentile of normal BMI women in the Women's Health Initiative [WHI]).

SECONDARY OBJECTIVE:

I. Assess preliminary efficacy of the intervention by evaluating the post-intervention differences between the intervention and control groups in:

IIa. Circulating markers of inflammation and metabolic dysfunction linked to both excess adiposity and breast cancer (high sensitivity C-reactive protein [hsCRP], fasting insulin, leptin, IL-6, triglycerides, sex hormone binding globulin [SHBG], adiponectin, and high density lipoprotein [HDL] cholesterol).

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: None

Eligibility Criteria

Ages: 50 Years to 69 Years (Adult, Older Adult)
Sex: Female
Accepts Healthy Volunteers: Yes

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).