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Sponsors and Collaborators: |
University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00393172 |
RATIONALE: Exercising regularly may lower the risk of breast cancer.
PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer in healthy young women.
Condition | Intervention |
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Breast Cancer |
Procedure: complementary or alternative medicine procedure Procedure: dual x-ray absorptometry Procedure: exercise intervention Procedure: mass spectrometry Procedure: observation Procedure: physiologic testing |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Active Control |
Official Title: | Women in Steady Exercise Research (WISER) |
Estimated Enrollment: | 400 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled study. Participants are stratified according to baseline body fat percentage and age (18 to 24 years vs 25 to 30 years). Participants are randomized to 1 of 2 intervention arms.
Participants undergo blood collection, body mass measurement by dual-energy x-ray absorptiometry, and a fitness assessment twice during the 6-month study.
PROJECTED ACCRUAL: A total of 400 participants will be accrued.
Ages Eligible for Study: | 18 Years to 30 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No medical condition that would prohibit participation in a vigorous program of weight-bearing aerobic exercise including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
University of Minnesota - St. Paul Campus | Recruiting |
St. Paul, Minnesota, United States, 55108 | |
Contact: Mindy Kurzer 612-624-9789 mkurzer@umn.edu | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kathryn H. Schmitz, MD 215-898-6604 |
Principal Investigator: | Mindy Kurzer | University of Minnesota |
Study ID Numbers: | CDR0000511819, UMN-0505M69867 |
Study First Received: | October 25, 2006 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00393172 |
Health Authority: | Unspecified |
breast cancer |
Skin Diseases Breast Neoplasms Healthy Breast Diseases |
Neoplasms Neoplasms by Site |