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

Phase 2

Completed

• Conditions: Breast Cancer; Obesity
• Interventions: Behavioral: exercise

• Registration Number: NCT00393172
• Lead Sponsor: University of Minnesota

Brief 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.

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, 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Primary Completion: 2009-09
• Study Completion: 2010-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise	exercise	5 days per week exercise for 4 months

Primary Outcome Measures

Name	Time	Method
Changes in urine levels of F2-isoprostanes	Before and after study

Secondary Outcome Measures

Name	Time	Method
Changes in levels of IGF-axis proteins	Before and after study
Changes in body composition	Before and after study
Changes in insulin and glucose	Before and after study
Changes in estrogen metabolites	Before and after study

Trial Locations

Locations (1)

University of Minnesota - St. Paul Campus; 🇺🇸 Saint Paul, Minnesota, United States