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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04267796
• Other study ID #: 2019-0634
• Secondary ID: NCI-2019-0763620
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• Employee at MD Anderson Cancer Center

• 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 wo or more times per week

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Foundation for Women's Cancers, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.	Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures	up to 16 weeks
Primary	Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.	Will assessed by the calculated rates, frequencies, and 95% confidence intervals (CIs) for these measures	up to 16 weeks

External Links

•   MD Anderson Cancer Center Website