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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Aerobic Exercise; Other: Dietary Intervention; Other: Resistance Training

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (lifestyle intervention); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Aerobic Exercise; Complete aerobic training; Other Names: Aerobic Activity; Other: Dietary Intervention; Receive diet recommendations from health coach or registered dietitian; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Resistance Training; Complete high-resistance circuit training sessions; Other Names: Strength Training
Active Comparator: Group II (wait-list, lifestyle intervention); Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Aerobic Exercise; Complete aerobic training; Other Names: Aerobic Activity; Other: Dietary Intervention; Receive diet recommendations from health coach or registered dietitian; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Resistance Training; Complete high-resistance circuit training sessions; Other Names: Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility Rate	Eligibility rate will be calculated as the number of eligible women identified divided by the total number completing a DXA scan. Criteria for feasibility will be defined as an eligibility rate of ≥ 40%	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Adherence	Intervention adherence for an individual is defined as attending at least 22 of the sessions with the personal trainer and at least 11 of the health coaching sessions. The intervention adherence at the study level is then defined by the percentage of participants adhering to the intervention. Criteria for feasibility will be defined as a study intervention adherence rate of ≥ 75%	4 months
Retention Rate	Retention will be assessed by the percentage of participants completing the 4-month study assessments. Criteria for feasibility will be defined as a retention rate of ≥ 80% in each arm.	8 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Foundation for Women's Cancers
• Investigators: Principal Investigator: Karen M Basen-Engquist, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): June 13, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Nutrition Therapy; Physical Conditioning, Human; Exercise; Resistance Training; Diet Therapy
• Other Study ID Numbers: 2019-0634 (Other Identifier: M D Anderson Cancer Center); NCI-2019-07636 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No