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Breast CancerPhase 2/3WISERNCT00393172

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

A Phase 2/3 study testing exercise in people with Breast Cancer and Obesity, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Obesity
What is being tested?
exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
May 2006to Mar 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • Female
  • Premenopausal
  • Body mass index 18.5 to 40
  • Stable weight (no changes ≥ 10% within the past year)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota - St. Paul Campus

    Saint Paul, Minnesota, 55108

Other trials in United States

About this study

Official title: Women in Steady Exercise Research (WISER)

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.

Read the 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.

Being tested
exercise
Keywords
exercise, breast cancer, prevention, obesity, estrogen metabolism, oxidative stress, IGF-1
Medical subject headings
Breast Neoplasms, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseBehavioural

    5 days per week exercise for 4 months

Study groups in NCT00393172
Study groupRoleWhat they receive
exerciseExperimental5 days per week exercise for 4 months
Receives: Behavioral: exercise
no exerciseNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in urine levels of F2-isoprostanes

    Measured: Before and after study

Secondary outcomes (4)

  1. Changes in levels of IGF-axis proteins

    Measured: Before and after study

  2. Changes in insulin and glucose

    Measured: Before and after study

  3. Changes in estrogen metabolites

    Measured: Before and after study

  4. Changes in body composition

    Measured: Before and after study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionSep 2009
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393172
Sponsor's protocol ID
FWA00000312-5
Other IDs
U54CA116849, UMN-0505M69867
Acronym
WISER
Status last verified
Oct 2019
First submitted
25 Oct 2006
Last updated
1 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Crawford TN, Arikawa AY, Kurzer MS, Schmitz KH, Phipps WR. Cross-sectional study of factors influencing sex hormone-binding globulin concentrations in normally cycling premenopausal women. Fertil Steril. 2015 Dec;104(6):1544-51. doi: 10.1016/j.fertnstert.2015.08.040. Epub 2015 Sep 16.

    PubMed 26385402

  • Arikawa AY, Jakits HE, Flood A, Thomas W, Gross M, Schmitz KH, Kurzer MS. Consumption of a high glycemic load but not a high glycemic index diet is marginally associated with oxidative stress in young women. Nutr Res. 2015 Jan;35(1):7-13. doi: 10.1016/j.nutres.2014.10.005. Epub 2014 Oct 16.

    PubMed 25453541

  • Smith AJ, Phipps WR, Thomas W, Schmitz KH, Kurzer MS. The effects of aerobic exercise on estrogen metabolism in healthy premenopausal women. Cancer Epidemiol Biomarkers Prev. 2013 May;22(5):756-64. doi: 10.1158/1055-9965.EPI-12-1325.

    PubMed 23652373

  • O'Dougherty M, Schmitz KH, Hearst MO, Covelli M, Kurzer MS. Dual conversations: body talk among young women and their social contacts. Qual Health Res. 2011 Sep;21(9):1191-204. doi: 10.1177/1049732311405804. Epub 2011 Apr 20.

    PubMed 21508251

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing exercise in people with Breast Cancer and Obesity, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in urine levels of F2-isoprostanes (time frame: Before and after study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393172, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.

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