Breast NeoplasmsPhase 3NCT00115713
Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy
A Phase 3 study testing Aerobic Exercise Training and Resistance Exercise Training in people with Breast Neoplasms, run by University of Alberta at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Aerobic Exercise Training and Resistance Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2003to Dec 2005
- Phase
- Phase 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Previous chemotherapy (previous cancer is NOT an exclusion criteria).
- Cancer recurrence.
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- 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).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G2H9
Ottawa Hospital
Ottawa, Ontario
University of British Columbia
Vancouver, British Columbia, V6T123
About this study
Official title: Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial
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.
Read the detailed description
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
- Breast Neoplasms
- Being tested
- Aerobic Exercise Training, Resistance Exercise Training
- Keywords
- Aerobic Exercise, Weight Lifting, Breast Cancer, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
Resistance Exercise TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Secondary outcomes (6)
Physical Fitness
Body Composition
Lymphedema
Treatment Completion Rates
Selected Biomarkers
Exercise Adherence Rates and Determinants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startApr 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Research Alliance
- Investigators
- Kerry S Courneya, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115713
- Sponsor's protocol ID
- ETH-02-70-85
- Status last verified
- Nov 2024
- First submitted
- 23 Jun 2005
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33779887Courneya 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.
PubMed 24633595Dolan 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.
PubMed 20861399Courneya 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.
PubMed 18954442
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial
- ClinicalTrials.gov ID
- NCT00115713
- Acronym / sponsor ID
- ETH-02-70-85
- Conditions
- Breast Neoplasms
- Keywords
- Aerobic Exercise, Weight Lifting, Breast Cancer, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Research Alliance
- Study start
- Apr 2003
- Study completion
- Dec 2005 (actual)
- First posted
- 24 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
- Previous chemotherapy (previous cancer is NOT an exclusion criteria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise Training | Behavioural | – |
| Resistance Exercise Training | Behavioural | – |
Primary outcome
Quality of Life
6 secondary outcomes
Physical Fitness
Body Composition
Lymphedema
Treatment Completion Rates
Selected Biomarkers
Exercise Adherence Rates and Determinants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 33779887An 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.
- Derived from this study: PubMed 24633595Courneya 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.
- Derived from this study: PubMed 20861399Dolan 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.
- Derived from this study: PubMed 18954442Courneya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry S Courneya, PhD principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aerobic Exercise Training and Resistance Exercise Training in people with Breast Neoplasms, run by University of Alberta at 3 sites in Canada.
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 8 inclusion and 10 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 phase mean?
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?
Quality of Life. 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 NCT00115713, 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 5 Nov 2024.