Breast Cancer Prevention
Conditions
Brief summary
The goals of the study are to examine the effect in postmenopausal women of a one-year moderate intensity exercise intervention, as compared with a sedentary pattern (low-level stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin, triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.
Interventions
BEHAVIORALExercise
Moderate intensity exercise, 5 days per week, 45 min per session, 50-70% max HR, divided into a 3-month individualized and 9-month maintenance period.
Sponsors
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 55-75 years at first group meeting * Physically able to undertake a moderate exercise program * Sedentary activity pattern (exercising \< 2 times/week for 20 minutes at a level to produce sweating) * Postmenopausal (not experiencing menstrual periods for the previous 12 months or FSH \>30 mIU/ml; for women who have had a hysterectomy, an FHS \>30 mIU/ml will classify them as postmenopausal) * Body Mass Index (BMI) greater than 25.0 * Able to follow directions and fill out questionnaires, and exercise diaries and logs in English * Agrees to be randomly assigned to either the exercise intervention or control group * Gives informed consent to participate in all screening and study activities * Able to come to the FHCRC for clinic visits and classes, to the UW Medical Center for CT scans, and to the UW NETT for measurements and instruction
Exclusion criteria
* Plans to leave Western Washington within the follow-up period * Using hormone replacement, tamoxifen, or oral contraceptives in past 6 months * Currently having severe hot flashes (that might prompt participant to start hormone replacement therapy before the end of study) * Current unstable thyroid disease or unstable dose of thyroid medications or TSH \>5.0 IU/ml or \<0.5 IU/ml * Invasive cancer in the past 10 years (except nonmelanotic skin cancer) * Any other endocrinologic abnormality * Breast, endometrial, ovarian, or melanoma cancer or carcinoma-in-situ at any time * Morbidly obese (BMI \> 40) * Current or planned use of corticosteroids * Currently on or planning to enter a structured weight loss program or to take diet drugs * Current use of certain other medications, such as any likely to interfere with adherence to an exercise program or likely to interfere with study outcomes * Moderate to high alcohol intake (more than 2 drinks per day) * Current smoker * Diabetes mellitus (fasting hyperglycemia) * Abnormal screening labs (hematocrit \< 32 or \> 48, white blood cells \< 3.0 or \> 15.0, potassium \< 3.5 or \> 5.0, fasting glucose \> 140, creatinine \> 2.0), or abnormalities on screening physical judged by study physicians to contraindicate participation in an exercise program * Contraindications for entry into a training program118 including: unstable angina, uncontrolled hypertension (systolic \> 200, diastolic \> 100), orthostatic hypotension (\> 20), moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, third degree heart block, pericarditis, myocarditis, pulmonary/systemic embolism within the past 6 months, thrombophlebitis, ST displacement \> 3 mm at rest, history of cardiac arrest) * Contraindications for exercise testing118 including: recent (within 6 months) cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality * Meets criteria to stop screening exercise test118 as decided by overseeing physician (Dr. Schwartz or McTiernan) * volunteering in order to lose weight * alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum total estrone concentration | Baseline, 3 month, 12-month |
Secondary
| Measure | Time frame |
|---|---|
| serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG). | baseline, 3 month, 12-month |
| Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1). | Basline, 3 month, 12-month |
| Adipose tissue stores: weight, body mass index, total fat mass, waist and hip circumferences and their ratio, and subcutaneous and intra-abdominal fat areas | Baseline, 3 month, 12 month |
| Fasting serum concentrations of insulin, glucose, and triglycerides | Baseline, 3 month, 12 month |
| Quality of life | Baseline, 3 month, 12 month |
Countries
United States
Outcome results
None listed