Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)]

Breast Cancer Clinical Trial

— WISER  

Official title:

Women in Steady Exercise Research (WISER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393172
• Other study ID #: FWA00000312-5
• Secondary ID: U54CA116849UMN-0
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2006
• Est. completion date: March 2010

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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, body composition (including body mass index, lean mass, and body fat [DEXA scan]).

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.

Other known NCT identifiers

• NCT00354718

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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)

• Female

• Premenopausal

• Body mass index 18.5 to 40

• Stable weight (no changes = 10% within the past year)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Obesity

Intervention

Behavioral:
• exercise
5 days per week exercise for 4 months

Locations

Country	Name	City	State
United States	University of Minnesota - St. Paul Campus	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in urine levels of F2-isoprostanes		Before and after study
Secondary	Changes in levels of IGF-axis proteins		Before and after study
Secondary	Changes in insulin and glucose		Before and after study
Secondary	Changes in estrogen metabolites		Before and after study
Secondary	Changes in body composition		Before and after study