NCT00393172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

October 25, 2006

Last Update Submit

October 30, 2019

Conditions

Breast CancerObesity

Keywords

exercisebreast cancerpreventionobesityestrogen metabolismoxidative stressIGF-1

Outcome Measures

Primary Outcomes (1)

  • Changes in urine levels of F2-isoprostanes

    Before and after study

Secondary Outcomes (4)

  • Changes in levels of IGF-axis proteins

    Before and after study

  • Changes in insulin and glucose

    Before and after study

  • Changes in estrogen metabolites

    Before and after study

  • Changes in body composition

    Before and after study

Study Arms (2)

exercise

EXPERIMENTAL

5 days per week exercise for 4 months

Behavioral: exercise

no exercise

NO INTERVENTION

Interventions

exerciseBEHAVIORAL

5 days per week exercise for 4 months

exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota - St. Paul Campus

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (4)

  • 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.

    PMID: 26385402DERIVED

  • 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.

    PMID: 25453541DERIVED

  • 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.

    PMID: 23652373DERIVED

  • 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.

    PMID: 21508251DERIVED

MeSH Terms

Conditions

Breast NeoplasmsObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mindy Kurzer

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2009

Study Completion

March 1, 2010

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

US(1)