Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy

NCT ID: NCT00115713

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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The study was a prospective, three-armed, randomized controlled trial. Participants were stratified by site (Edmonton, Ottawa, and Vancouver) and planned chemotherapy protocol (taxane-based versus nontaxane-based) and randomly assigned to AET, RET, or usual care (UC) in a 1:1:1 ratio using a random-numbers table. Participants assigned to the AET group were asked to perform aerobic exercise three times per week on a recumbent or upright cycle ergometer, treadmill, or elliptical. Exercise duration began at 15 minutes for weeks 0 through 2, and then systematically increased by 5 minutes every three weeks thereafter to 45 minutes for weeks 18 and beyond. Exercise intensity began at 60% of VO2max for weeks 0 through 2 and then systematically increased by 10% every 6 weeks thereafter to 80% of VO2max for weeks 12 and beyond. Warm-up and cool-down periods consisted of 5 minutes of aerobic activity at the power output of the ventilatory equivalent for oxygen (approximately 50% of peak oxygen consumption). Participants assigned to the RET group were asked to perform resistance exercise three times per week, which consisted of two sets of 10 repetitions of 9 different exercises performed at 60-70% of 1-repetition maximum. The specific exercises were: leg extension, leg curl, calf raises, chest press, latissimus pulldown, overhead press, triceps extension, biceps curls, and modified curl-ups. Resistance was increased by approximately 10% or the next weight level when the participant was able to complete 12 repetitions per set without difficulty.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aerobic Exercise Training

Intervention Type BEHAVIORAL

Resistance Exercise Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)
* 18+ years of age
* No uncontrolled hypertension, cardiac illness, psychiatric condition
* No contraindication to exercise as determined by a fitness test

Exclusion Criteria

* 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).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Breast Cancer Research Alliance

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Principal Investigators

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Kerry S Courneya, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33779887 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24633595 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20861399 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18954442 (View on PubMed)

Other Identifiers

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ETH-02-70-85

Identifier Type: -

Identifier Source: org_study_id

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