Effect of Exercise on Sex Hormones in Postmenopausal Women

Phase 2

Completed

• Conditions: Breast Cancer Prevention
• Interventions: Behavioral: Exercise

• Registration Number: NCT00668174
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-01
• Primary Completion: 2003-12
• Study Completion: 2004-12
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-29
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 173

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Exercise	Exercise

Primary Outcome Measures

Name	Time	Method
Serum total estrone concentration	Baseline, 3 month, 12-month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States