Effect of Exercise on Sex Hormones in Postmenopausal Women

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Breast Cancer Prevention

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00668174

IR-4290

PATH - CA/AG69334-01A2,

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

Female

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)