NCT00115713

Brief Summary

The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2003

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

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

April 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

First QC Date

June 23, 2005

Last Update Submit

November 4, 2024

Conditions

Breast Neoplasms

Keywords

Aerobic ExerciseWeight LiftingBreast CancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

Secondary Outcomes (6)

  • Physical Fitness

  • Body Composition

  • Lymphedema

  • Treatment Completion Rates

  • Selected Biomarkers

  • +1 more secondary outcomes

Interventions

Aerobic Exercise TrainingBEHAVIORAL
Resistance Exercise TrainingBEHAVIORAL

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer early stage I -IIIA
  • Completed axillary surgery
  • Scheduled to receive adjuvant chemotherapy for 9 - 24 weeks
  • Approval of the treating oncologist
  • Able to understand and provide written informed consent in English or French (Ottawa)
  • + years of age
  • No uncontrolled hypertension, cardiac illness, psychiatric condition
  • No contraindication to exercise as determined by a fitness test

You may not qualify if:

  • Pregnant.
  • Unwilling to accept randomization.
  • Any medical condition that would be a contraindication to exercise. The clinicians will make this decision.
  • Unwilling to travel to/participate in the exercise program as defined by the protocol.
  • Cancer recurrence.
  • Planned/known absence of greater than 2 weeks during the intended study period.
  • Previous therapy for known breast cancer.
  • Those who have had TRAM (i.e., Transabdominal Rectus Abdominus Muscle Reconstructive Surgery) done.
  • Moderate lymphedema (\>20% or \>200mL difference between the affected arm and the unaffected arm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alberta

Edmonton, Alberta, T6G2H9, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T123, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

Related Publications (4)

  • An KY, Arthuso FZ, Kang DW, Morielli AR, Ntoukas SM, Friedenreich CM, McKenzie DC, Gelmon K, Mackey JR, Courneya KS. Exercise and health-related fitness predictors of chemotherapy completion in breast cancer patients: pooled analysis of two multicenter trials. Breast Cancer Res Treat. 2021 Jul;188(2):399-407. doi: 10.1007/s10549-021-06205-8. Epub 2021 Mar 29.

    PMID: 33779887DERIVED

  • Courneya KS, Segal RJ, McKenzie DC, Dong H, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Crawford JJ, Mackey JR. Effects of exercise during adjuvant chemotherapy on breast cancer outcomes. Med Sci Sports Exerc. 2014 Sep;46(9):1744-51. doi: 10.1249/MSS.0000000000000297.

    PMID: 24633595DERIVED

  • Dolan LB, Gelmon K, Courneya KS, Mackey JR, Segal RJ, Lane K, Reid RD, McKenzie DC. Hemoglobin and aerobic fitness changes with supervised exercise training in breast cancer patients receiving chemotherapy. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2826-32. doi: 10.1158/1055-9965.EPI-10-0521. Epub 2010 Sep 22.

    PMID: 20861399DERIVED

  • Courneya KS, Reid RD, Friedenreich CM, Gelmon K, Proulx C, Vallance JK, McKenzie DC, Segal RJ. Understanding breast cancer patients' preference for two types of exercise training during chemotherapy in an unblinded randomized controlled trial. Int J Behav Nutr Phys Act. 2008 Oct 27;5:52. doi: 10.1186/1479-5868-5-52.

    PMID: 18954442DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kerry S Courneya, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2005

First Posted

June 24, 2005

Study Start

April 1, 2003

Study Completion

December 1, 2005

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

CA(3)