NCT04267796

Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

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). IIb. Body composition body fat, trunk fat mass, fat mass, lean mass, fat-free mass). EXPLORATORY OBJECTIVE: I. Exploratory outcomes include fitness (oxygen consumption VO2 peak, sit-to-stand test), behavior (physical activity, energy intake, macronutrient consumption), and quality of life (global health-related quality of life, physical functioning, sleep, menopausal symptoms). OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: 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: Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Aerobic Exercise	Complete aerobic training
OTHER	Dietary Intervention	Receive diet recommendations from health coach or registered dietitian
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Resistance Training	Complete high-resistance circuit training sessions

Timeline

• Start date: 2021-06-25
• Primary completion: 2025-06-13
• Completion: 2026-07-01
• First posted: 2020-02-13
• Last updated: 2026-04-16
• Results posted: 2026-04-16

Locations

1 site across 1 country: United States