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Exercise in Preventing Breast Cancer in Healthy Young Women
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008
Sponsors and Collaborators: University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00393172
  Purpose

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
Breast Cancer
Procedure: complementary or alternative medicine procedure
Procedure: dual x-ray absorptometry
Procedure: exercise intervention
Procedure: mass spectrometry
Procedure: observation
Procedure: physiologic testing

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness
Drug Information available for: X-Rays
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Active Control
Official Title: Women in Steady Exercise Research (WISER)

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

Primary Outcome Measures:
  • Changes in urine levels of F2-isoprostanes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationships between physiologic pathways that may reduce risk of breast cancer [ Designated as safety issue: No ]
  • Cumulative incidence of shortened luteal phase length and anovulatory menstrual cycles [ Designated as safety issue: No ]
  • Comparison of demographic and physiologic predictors of the onset of shortened luteal phase (< 10 days) and/or anovulation [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Compare the changes in urine levels of a stable marker of oxidative stress (F_2-isoprostanes) in healthy young women who undergo exercise training during 4 menstrual cycles vs no exercise.

Secondary

  • Assess the changes in other metabolic factors that explain the association between physical activity and breast cancer, including estrogen metabolism (estrone, estradiol, estriol, 2-OHE_1, 2-OHE_2, 2-MeOHE_1, 2-MeOHE_2, 4-OHE_1, 4-OHE_2 [as well as ratios of these metabolites]), insulin-like growth factor (IGF)-1 (as well as IGF-binding proteins-1, -2, and -3), insulin, glucose, insulin resistance, and body composition (including body mass index, lean mass, and body fat [DEXA scan]).
  • Determine potential relationships between physiologic pathways that may reduce risk of breast cancer.
  • Compare the cumulative incidence of shortened luteal phase length and anovulatory menstrual cycles in these participants.
  • Compare demographic and physiologic predictors of the onset of shortened luteal phases (< 10 days) and/or anovulation in these participants.

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.

  • Arm I: Participants exercise for 30 minutes 5 times a week. The intensity of exercise is increased every 4 weeks. The exercise regimen continues for up to 4 menstrual cycles.
  • Arm II: Participants are observed for 4 menstrual cycles. Participants in both arms undergo 24-hour collection of urine on days 7, 8, and 9 of menstrual cycles 1 and 6. F_2-isoprostanes are measured via gas chromatography-mass spectrometry (GC/MS). Estrogens are also measured by GC/MS and include E_1, E_2, E_3, 2-OHE_1, 2-OHE_2, 4-OHE_1, 4-OHE_2, 2-MeE_1, 2-MeE_2, 4-MeE_1, 4-MeE_2, and 16OHE_1.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy women
  • Self-reported menstrual cycle length of 25-35 days within the past 2 months
  • Nonsmoker
  • Sedentary (exercise < 3 times weekly within the past 6 months)
  • Intact ovaries and uterus
  • No history of gynecological problems (e.g., fibroids, endometriosis, polycystic ovary syndrome)

PATIENT CHARACTERISTICS:

  • Female
  • Premenopausal
  • Body mass index 18.5 to 40
  • Stable weight (no changes ≥ 10% within the past year)
  • No pregnancy or breast feeding within the past 6 months
  • No plans to become pregnant during study treatment
  • No cancer within the past 5 years except for nonmelanoma skin cancers
  • 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:

    • Fibromyalgia
    • Chronic fatigue syndrome
    • Metabolic disorders
    • Recent cardiovascular event
    • Orthopedic limitations
    • Psychiatric disorders requiring antipsychotic drugs
  • No uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg and/or diastolic BP > 99 mm Hg)
  • No more than 7 alcoholic beverages per week

PRIOR CONCURRENT THERAPY:

  • No injected hormonal contraceptive use within the past year
  • More than 6 months since prior use of intrauterine device
  • More than 3 months since prior oral or patch hormone contraceptives
  • No medication that would prohibit participation in a vigorous program of weight-bearing aerobic exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393172

Locations
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        
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Mindy Kurzer University of Minnesota
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000511819, UMN-0505M69867
Study First Received: October 25, 2006
Last Updated: July 25, 2008
ClinicalTrials.gov Identifier: NCT00393172  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009