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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania Identifier:
First received: May 1, 2009
Last updated: February 17, 2016
Last verified: February 2016

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single
Official Title: Women In Steady Exercise Research (WISER) Sister

Resource links provided by NLM:

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

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

Secondary Outcome Measures:
  • Effects of exercise on variables known to affect or reflect mitogenic activity as related to breast cancer risk
  • Changes in other physiologic parameters associated with breast mitotic activity
  • Extent to which changes in body composition and body mass mediate observed changes in E1G-AUC
  • 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)

Enrollment: 183
Study Start Date: October 2008
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00892515     History of Changes
Other Study ID Numbers: CDR0000617105
Study First Received: May 1, 2009
Last Updated: February 17, 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 processed this record on September 21, 2017