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Breast Cancer PreventionPhase 2/3NCT00668174

Effect of Exercise on Sex Hormones in Postmenopausal Women

A Phase 2/3 study testing Exercise in people with Breast Cancer Prevention, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer Prevention
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteUnited States
Study dates
Jan 1997to Dec 2004
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98102

Other trials in United States

About this study

Official title: Physical Activity and Total Health Trial

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.

Being tested
Exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

Study groups in NCT00668174
Study groupRoleWhat they receive
1ExperimentalExercise
Receives: Behavioral: Exercise
2No interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum total estrone concentration

    Measured: Baseline, 3 month, 12-month

Secondary outcomes (5)

  1. serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).

    Measured: baseline, 3 month, 12-month

  2. Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).

    Measured: Basline, 3 month, 12-month

  3. Adipose tissue stores: weight, body mass index, total fat mass, waist and hip circumferences and their ratio, and subcutaneous and intra-abdominal fat areas

    Measured: Baseline, 3 month, 12 month

  4. Fasting serum concentrations of insulin, glucose, and triglycerides

    Measured: Baseline, 3 month, 12 month

  5. Quality of life

    Measured: Baseline, 3 month, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2008 (estimated)
  2. Study startJan 1997
  3. Primary completionDec 2003
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668174
Sponsor's protocol ID
PATH - CA/AG69334-01A2,
Other IDs
IR-4290
Status last verified
Nov 2012
First submitted
25 Apr 2008
Last updated
28 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1152/japplphysiol.01349.2007. Epub 2008 Apr 10.

    PubMed 18403448

  • 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. doi: 10.1016/j.jada.2007.10.037.

    PubMed 18155998

  • 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(5):895-9. doi: 10.1158/1055-9965.EPI-06-0701.

    PubMed 17507612

  • 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. doi: 10.1016/j.cct.2007.01.002. Epub 2007 Jan 12.

    PubMed 17287149

  • 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. doi: 10.1016/j.amjmed.2006.06.033.

    PubMed 17071161

  • 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. doi: 10.1186/1479-5868-3-34.

    PubMed 17020620

  • 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):466-75. doi: 10.1038/sj.ijo.0803438. Epub 2006 Aug 15.

    PubMed 16909130

  • 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. doi: 10.1249/01.mss.0000227308.11278.d7.

    PubMed 16826020

  • 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. doi: 10.1249/01.mss.0000184584.95000.e4.

    PubMed 16531889

  • 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. doi: 10.1089/jwh.2005.14.704.

    PubMed 16232102

  • 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 clinical trial. Obes Res. 2005 Mar;13(3):615-25. doi: 10.1038/oby.2005.66.

    PubMed 15833948

  • 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 randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1020-1. doi: 10.1158/1055-9965.EPI-04-0834. No abstract available.

    PubMed 15824183

  • 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):774-82. doi: 10.1200/JCO.2005.04.036.

    PubMed 15681521

  • 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. doi: 10.1210/jc.2004-2081. Epub 2004 Dec 7.

    PubMed 15585547

  • 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 postmenopausal women. Prev Med. 2004 Dec;39(6):1080-6. doi: 10.1016/j.ypmed.2004.04.017.

    PubMed 15539040

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Exercise in people with Breast Cancer Prevention, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum total estrone concentration (time frame: Baseline, 3 month, 12-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00668174, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.

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