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Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer

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ClinicalTrials.gov Identifier: NCT00892515
Recruitment Status : Unknown
Verified February 2016 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2009
Last Update Posted : February 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:

RATIONALE: Exercise may change the risk of developing breast cancer. It is not yet known whether low-intensity exercise or high-intensity exercise is more effective in lowering the risk of breast cancer.

PURPOSE: This randomized clinical trial is studying how well exercise programs work in healthy young women at increased risk of developing breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Healthy, no Evidence of Disease Behavioral: exercise intervention Other: counseling intervention Other: gas chromatography Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis Other: mass spectrometry Other: physiologic testing Other: questionnaire administration Other: survey administration Procedure: dual x-ray absorptometry Procedure: magnetic resonance imaging Procedure: study of high risk factors

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Masking: Single
Official Title: Women In Steady Exercise Research (WISER) Sister
Study Start Date : October 2008
Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length

Secondary Outcome Measures :
  1. Effects of exercise on variables known to affect or reflect mitogenic activity as related to breast cancer risk
  2. Changes in other physiologic parameters associated with breast mitotic activity
  3. Extent to which changes in body composition and body mass mediate observed changes in E1G-AUC
  4. Relationship between estrogen and progesterone from daily urinary measurements with observed menstrual cycle alterations (i.e., follicular and luteal phase length changes, and ovulatory status)

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


  • Healthy women with ≥ 18% lifetime risk for breast cancer as evidenced by the following:

    • Documentation from a genetic counselor of a known familial breast cancer susceptibility mutation
    • Claus model risk of ≥18%
    • Predicted probability of BRCA1/2 mutation > 25% based on the Myriad model
    • Documentation of a known mutation in a family member such that the Mendelian probability of a BRCA1/2 mutation would be >25%
    • History of lobular carcinoma in situ
  • No prior prophylactic mastectomy
  • Leisure-time exercise energy expenditure of ≤ 500 kcal/week over the past 6 months
  • Hormone receptor status not specified


  • Premenopausal
  • Menstrual cycles 25-32 days in length
  • Intact ovaries and uterus
  • Gynecologic age (defined as participant's current age minus the age at which she started menstruating) of at least 4 years
  • Body mass index 21-50
  • No history of menstrual difficulties
  • No history of physician-diagnosed gynecological disease (e.g., fibroids, endometriosis, or polycystic ovary syndrome)
  • Not pregnant
  • Not planning to become pregnant during the study period
  • No medical conditions or medications that would prohibit participation in aerobic exercise or would negatively impact the study
  • No history of cancer, except nonmelanoma skin cancers, and in situ cervical cancers
  • No eating disorders (e.g., bulimia or binge-eating disorder)
  • At least one year since prior smoking
  • Not planning to move away from the area during the period of the study
  • No concurrent participation in any weight loss programs


  • See Disease Characteristics
  • At least 3 months since prior hormonal contraception
  • Must use effective non-hormonal contraception unless participant has undergone prior tubal ligation
  • Consumes no more than 7 alcoholic beverages per week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892515

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Katie Schmitz, PhD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00892515     History of Changes
Other Study ID Numbers: CDR0000617105
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
breast cancer
healthy, no evidence of disease

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases