Effect of Exercise on Sex Hormones in Postmenopausal Women

Breast Cancer Prevention Clinical Trial

Official title:

Physical Activity and Total Health Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668174
• Other study ID #: PATH - CA/AG69334-01A2,
• Secondary ID: IR-4290
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 25, 2008
• Last updated: November 26, 2012
• Start date: January 1997
• Est. completion date: December 2004

Study information

• Verified date: November 2012
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer Prevention

Intervention

Behavioral:
• Exercise
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.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

References & Publications (25)

Aiello EJ, Yasui Y, Tworoger SS, Ulrich CM, Irwin ML, Bowen D, Schwartz RS, Kumai C, Potter JD, McTiernan A. Effect of a yearlong, moderate-intensity exercise intervention on the occurrence and severity of menopause symptoms in postmenopausal women. Menop — View Citation

Atkinson C, Lampe JW, Tworoger SS, Ulrich CM, Bowen D, Irwin ML, Schwartz RS, Rajan BK, Yasui Y, Potter JD, McTiernan A. Effects of a moderate intensity exercise intervention on estrogen metabolism in postmenopausal women. Cancer Epidemiol Biomarkers Prev — View Citation

Bowen DJ, Fesinmeyer MD, Yasui Y, Tworoger S, Ulrich CM, Irwin ML, Rudolph RE, LaCroix KL, Schwartz RR, McTiernan A. Randomized trial of exercise in sedentary middle aged women: effects on quality of life. Int J Behav Nutr Phys Act. 2006 Oct 4;3:34. — View Citation

Boynton A, Neuhouser ML, Sorensen B, McTiernan A, Ulrich CM. Predictors of diet quality among overweight and obese postmenopausal women. J Am Diet Assoc. 2008 Jan;108(1):125-30. — View Citation

Campbell PT, Wener MH, Sorensen B, Wood B, Chen-Levy Z, Potter JD, McTiernan A, Ulrich CM. Effect of exercise on in vitro immune function: a 12-month randomized, controlled trial among postmenopausal women. J Appl Physiol (1985). 2008 Jun;104(6):1648-55. — View Citation

Chubak J, McTiernan A, Sorensen B, Wener MH, Yasui Y, Velasquez M, Wood B, Rajan KB, Wetmore CM, Potter JD, Ulrich CM. Moderate-intensity exercise reduces the incidence of colds among postmenopausal women. Am J Med. 2006 Nov;119(11):937-42. — View Citation

Chubak J, Tworoger SS, Yasui Y, Ulrich CM, Stanczyk FZ, McTiernan A. Associations between reproductive and menstrual factors and postmenopausal androgen concentrations. J Womens Health (Larchmt). 2005 Oct;14(8):704-12. — View Citation

Chubak J, Tworoger SS, Yasui Y, Ulrich CM, Stanczyk FZ, McTiernan A. Associations between reproductive and menstrual factors and postmenopausal sex hormone concentrations. Cancer Epidemiol Biomarkers Prev. 2004 Aug;13(8):1296-301. — View Citation

Chubak J, Ulrich CM, Tworoger SS, Sorensen B, Yasui Y, Irwin ML, Stanczyk FZ, Potter JD, McTiernan A. Effect of exercise on bone mineral density and lean mass in postmenopausal women. Med Sci Sports Exerc. 2006 Jul;38(7):1236-44. — View Citation

Foster-Schubert KE, McTiernan A, Frayo RS, Schwartz RS, Rajan KB, Yasui Y, Tworoger SS, Cummings DE. Human plasma ghrelin levels increase during a one-year exercise program. J Clin Endocrinol Metab. 2005 Feb;90(2):820-5. Epub 2004 Dec 7. — View Citation

Frank LL, Sorensen BE, Yasui Y, Tworoger SS, Schwartz RS, Ulrich CM, Irwin ML, Rudolph RE, Rajan KB, Stanczyk F, Bowen D, Weigle DS, Potter JD, McTiernan A. Effects of exercise on metabolic risk variables in overweight postmenopausal women: a randomized c — View Citation

Frankenfeld CL, McTiernan A, Aiello EJ, Thomas WK, LaCroix K, Schramm J, Schwartz SM, Holt VL, Lampe JW. Mammographic density in relation to daidzein-metabolizing phenotypes in overweight, postmenopausal women. Cancer Epidemiol Biomarkers Prev. 2004 Jul;1 — View Citation

Irwin ML, McTiernan A, Baumgartner RN, Baumgartner KB, Bernstein L, Gilliland FD, Ballard-Barbash R. Changes in body fat and weight after a breast cancer diagnosis: influence of demographic, prognostic, and lifestyle factors. J Clin Oncol. 2005 Feb 1;23(4 — View Citation

Irwin ML, Tworoger SS, Yasui Y, Rajan B, McVarish L, LaCroix K, Ulrich CM, Bowen D, Schwartz RS, Potter JD, McTiernan A. Influence of demographic, physiologic, and psychosocial variables on adherence to a yearlong moderate-intensity exercise trial in post — View Citation

Irwin ML, Yasui Y, Ulrich CM, Bowen D, Rudolph RE, Schwartz RS, Yukawa M, Aiello E, Potter JD, McTiernan A. Effect of exercise on total and intra-abdominal body fat in postmenopausal women: a randomized controlled trial. JAMA. 2003 Jan 15;289(3):323-30. — View Citation

Littman AJ, Vitiello MV, Foster-Schubert K, Ulrich CM, Tworoger SS, Potter JD, Weigle DS, McTiernan A. Sleep, ghrelin, leptin and changes in body weight during a 1-year moderate-intensity physical activity intervention. Int J Obes (Lond). 2007 Mar;31(3):4 — View Citation

McTiernan A, Sorensen B, Yasui Y, Tworoger SS, Ulrich CM, Irwin ML, Rudolph RE, Stanczyk FZ, Schwartz RS, Potter JD. No effect of exercise on insulin-like growth factor 1 and insulin-like growth factor binding protein 3 in postmenopausal women: a 12-month — View Citation

McTiernan A, Tworoger SS, Rajan KB, Yasui Y, Sorenson B, Ulrich CM, Chubak J, Stanczyk FZ, Bowen D, Irwin ML, Rudolph RE, Potter JD, Schwartz RS. Effect of exercise on serum androgens in postmenopausal women: a 12-month randomized clinical trial. Cancer E — View Citation

McTiernan A, Tworoger SS, Ulrich CM, Yasui Y, Irwin ML, Rajan KB, Sorensen B, Rudolph RE, Bowen D, Stanczyk FZ, Potter JD, Schwartz RS. Effect of exercise on serum estrogens in postmenopausal women: a 12-month randomized clinical trial. Cancer Res. 2004 A — View Citation

Mohanka M, Irwin M, Heckbert SR, Yasui Y, Sorensen B, Chubak J, Tworoger SS, Ulrich CM, McTiernan A. Serum lipoproteins in overweight/obese postmenopausal women: a one-year exercise trial. Med Sci Sports Exerc. 2006 Feb;38(2):231-9. — View Citation

Rhew I, Yasui Y, Sorensen B, Ulrich CM, Neuhouser ML, Tworoger SS, Chubak J, Bowen DJ, McTiernan A. Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women. Contemp Clin Trials. 2007 Jul;28(4):472-81. Epub 2 — View Citation

Shade ED, Ulrich CM, Wener MH, Wood B, Yasui Y, Lacroix K, Potter JD, McTiernan A. Frequent intentional weight loss is associated with lower natural killer cell cytotoxicity in postmenopausal women: possible long-term immune effects. J Am Diet Assoc. 2004 — View Citation

Tworoger SS, Chubak J, Aiello EJ, Yasui Y, Ulrich CM, Farin FM, Stapleton PL, Irwin ML, Potter JD, Schwartz RS, McTiernan A. The effect of CYP19 and COMT polymorphisms on exercise-induced fat loss in postmenopausal women. Obes Res. 2004 Jun;12(6):972-81. — View Citation

Tworoger SS, Sorensen B, Chubak J, Irwin M, Stanczyk FZ, Ulrich CM, Potter J, McTiernan A. Effect of a 12-month randomized clinical trial of exercise on serum prolactin concentrations in postmenopausal women. Cancer Epidemiol Biomarkers Prev. 2007 May;16( — View Citation

Tworoger SS, Yasui Y, Vitiello MV, Schwartz RS, Ulrich CM, Aiello EJ, Irwin ML, Bowen D, Potter JD, McTiernan A. Effects of a yearlong moderate-intensity exercise and a stretching intervention on sleep quality in postmenopausal women. Sleep. 2003 Nov 1;26 — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum total estrone concentration		Baseline, 3 month, 12-month	No
Secondary	serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).		baseline, 3 month, 12-month	No
Secondary	Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).		Basline, 3 month, 12-month	No
Secondary	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	No
Secondary	Fasting serum concentrations of insulin, glucose, and triglycerides		Baseline, 3 month, 12 month	No
Secondary	Quality of life		Baseline, 3 month, 12 month	No