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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00892515
First received: May 1, 2009
Last updated: May 8, 2010
Last verified: July 2009
  Purpose

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 Blind
Official Title: Women In Steady Exercise Research (WISER) Sister

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of exercise on variables known to affect or reflect mitogenic activity as related to breast cancer risk [ Designated as safety issue: No ]
  • Changes in other physiologic parameters associated with breast mitotic activity [ Designated as safety issue: No ]
  • Extent to which changes in body composition and body mass mediate observed changes in E1G-AUC [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2008
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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 ClinicalTrials.gov identifier: NCT00892515

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Study Chair: Lorita Grant, MPH, MSW Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Kathryn H. Schmitz, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00892515     History of Changes
Other Study ID Numbers: CDR0000617105, UPCC-807822, UPCC-09108
Study First Received: May 1, 2009
Last Updated: May 8, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer
healthy, no evidence of disease

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

ClinicalTrials.gov processed this record on October 22, 2014