Breast Cancer Clinical Trial
Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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