Breast CancerPhase 3NCT00249015
Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors
A Phase 3 study testing Physical exercise in people with Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy, but there have not been any studies on weight training. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Mar 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
- Are diagnosed with stage I-IIIA breast cancer, histologically confirmed
- Are scheduled to receive adjuvant chemotherapy (receiving neoadjuvant chemotherapy for locally advanced cancer is an exclusion criteria)
- Have not received previous chemotherapy (previous cancer is NOT an exclusion criteria)
- Have not received transabdominal rectus abdominis muscle (TRAM) reconstructive surgery
- Are 18 years or older
- Received approval from their treating oncologist
- No uncontrolled hypertension, cardiac illness or psychiatric condition or any other medical condition that would be a contraindication to exercise
- Able to understand and provide written informed consent in English or French (Ottawa)
- Complete maximal aerobic and strength tests. No contraindication to exercise as determined by fitness tests
- Are not pregnant
- Willing to accept randomization and complete their assigned exercise program
- If participant is currently exercising (e.g., swimming at the Y 3 times per week) must be willing to give this up in place of their randomly assigned program
- Willing to travel to fitness center 3 times/week to complete exercise program
- Willing to complete all assessments (except blood) at all timepoints including 6, 12, and 24 month follow-ups
- Must not have a planned/known absence of greater than 2 weeks during the intended intervention period and must be able/willing to perform exercise sessions on their own during any planned absences of less than 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors. The CARE Trial.
Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy, but there have not been any studies on weight training. In this study, the researchers want to determine if a combined program of endurance and weight training exercises is better than a standard amount of endurance exercise or even a higher amount of endurance exercise in breast cancer survivors receiving chemotherapy. The study will be an experimental design in which the researchers have breast cancer survivors participate in one of the three different exercise programs. The researchers' main interest is in patient rated physical functioning and quality of life, which they will measure before and after the exercise programs by asking participants how they feel on various rating scales. The researchers will also measure their aerobic fitness on a treadmill and how strong they are by having them lift weights.
Read the detailed description
BACKGROUND: Aerobic exercise has been shown to improve physical fitness and quality of life (QoL) in breast cancer survivors receiving chemotherapy but no study to date has examined the addition of resistance exercise to aerobic exercise in this population. Resistance exercise has proven to be an important adjunct to aerobic exercise in the cardiac rehabilitation population although few trials have controlled for the total volume of exercise.
PURPOSE: The primary purpose of the present trial is to compare the effects of a combined aerobic and resistance exercise program (COMB) to a standard moderate volume of aerobic exercise (STAN) and a higher volume of aerobic exercise (HIGH) that controls for the total volume of exercise in the COMB arm.
METHODS: The study will be a prospective, three-armed, randomized controlled trial conducted in Edmonton (coordinating center), Ottawa, and Vancouver. Participants will be 300 breast cancer survivors scheduled to receive adjuvant chemotherapy. All three exercise groups will be asked to perform supervised exercise 3 days/week for the length of their chemotherapy treatment. The STAN group will be asked to perform approximately 500 kilocalories/week of self-selected aerobic activities (e.g., treadmill, cycle ergometer, elliptical). This arm of the trial is considered standard care based on the emerging consensus of recent systematic reviews and recommendations from major cancer agencies. The HIGH group will be asked to complete approximately 1,000 kilocalories/week of self-selected aerobic activities. The COMB group will be asked to complete 1,000 kilocalories/week split equally between aerobic and resistance exercise. The primary endpoint in the trial will be change in physical functioning between baseline and post intervention as assessed by the physical functioning subscale of the Short Form (SF) 36 scale. Secondary endpoints will include cardiorespiratory fitness (maximal treadmill test), muscular strength (8 repetition maximum tests), muscular endurance (standard load test at 50% of estimated baseline maximum), body composition (DEXA scans), psychological distress, sleep quality, exercise adherence, and chemotherapy completion rates.
RELEVANCE: An important issue for breast cancer survivors receiving chemotherapy is whether there is any advantage to increasing the volume of aerobic exercise or adding resistance exercise to a standard aerobic exercise program. If there is an advantage, then it is important that breast cancer survivors receive this optimal exercise prescription to maximize their ability to cope with their chemotherapy treatments and maintain their physical function and QoL during this difficult time.
- Conditions
- Breast Cancer
- Being tested
- Physical exercise
- Keywords
- aerobic exercise, resistance exercise, physical fitness, body composition, quality of life, rehabilitation, psychosocial oncology, adherence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
perform exercise program 3 days per week and 5 minutes of warm-up and cool-down exercises before and after the main exercise component
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Combined Aerobic and Resistance Exercise Program: perform three exercise sessions per week consisting of about 25-30 minutes of aerobic exercise at a moderate-to-vigorous intensity as well as some weight training consisting of two sets of 8-12 repetitions of 9-10 different exercises. For the aerobic exercise, participant can choose from different exercise equipment such as a treadmill or stationary bicycle. Receives: Behavioral: Physical exercise |
| 2 | Active comparator | Moderate Aerobic Exercise Group: perform three exercise sessions per week consisting of about 25-30 minutes of aerobic exercise at a moderate-to-vigorous intensity. Again, participant can choose from different exercise equipment. Receives: Behavioral: Physical exercise |
| 3 | Experimental | High Aerobic Exercise Group: perform three exercise sessions per week consisting of about 45-60 minutes of aerobic exercise at a moderate-to-vigorous intensity. Again, participant can choose from different exercise equipment. Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated physical functioning
Measured: at 8 weeks and 24 weeks
Secondary outcomes (1)
Physical fitness, body composition, treatment completion rates, exercise adherence rates, adverse events
Measured: at 8 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startJan 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry Courneya, PhD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249015
- Sponsor's protocol ID
- BR-01-0080 ethics 22148
- Status last verified
- Jun 2014
- First submitted
- 4 Nov 2005
- Last updated
- 18 Jul 2016
- 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 33779887An KY, Kang DW, Morielli AR, Friedenreich CM, Reid RD, McKenzie DC, Gelmon K, Mackey JR, Courneya KS. Patterns and predictors of exercise behavior during 24 months of follow-up after a supervised exercise program during breast cancer chemotherapy. Int J Behav Nutr Phys Act. 2020 Feb 14;17(1):23. doi: 10.1186/s12966-020-00924-9.
PubMed 32059728Courneya KS, Segal RJ, Vallerand JR, Forbes CC, Crawford JJ, Dolan LB, Friedenreich CM, Reid RD, Gelmon K, Mackey JR, McKenzie DC. Motivation for Different Types and Doses of Exercise During Breast Cancer Chemotherapy: a Randomized Controlled Trial. Ann Behav Med. 2016 Aug;50(4):554-63. doi: 10.1007/s12160-016-9782-z.
PubMed 26896305
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors. The CARE Trial.
- ClinicalTrials.gov ID
- NCT00249015
- Acronym / sponsor ID
- BR-01-0080 ethics 22148
- Conditions
- Breast Cancer
- Keywords
- aerobic exercise, resistance exercise, physical fitness, body composition, quality of life, rehabilitation, psychosocial oncology, adherence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Nov 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.
Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy, but there have not been any studies on weight training. In this study, the researchers want to determine if a combined program of endurance and weight training exercises is better than a standard amount of endurance exercise or even a higher amount of endurance exercise in breast cancer survivors receiving chemotherapy. The study will be an experimental design in which the researchers have breast cancer survivors participate in one of the three different exercise programs. The researchers' main interest is in patient rated physical functioning and quality of life, which they will measure before and after the exercise programs by asking participants how they feel on various rating scales. The researchers will also measure their aerobic fitness on a treadmill and how strong they are by having them lift weights.
Detailed description
BACKGROUND: Aerobic exercise has been shown to improve physical fitness and quality of life (QoL) in breast cancer survivors receiving chemotherapy but no study to date has examined the addition of resistance exercise to aerobic exercise in this population. Resistance exercise has proven to be an important adjunct to aerobic exercise in the cardiac rehabilitation population although few trials have controlled for the total volume of exercise.
PURPOSE: The primary purpose of the present trial is to compare the effects of a combined aerobic and resistance exercise program (COMB) to a standard moderate volume of aerobic exercise (STAN) and a higher volume of aerobic exercise (HIGH) that controls for the total volume of exercise in the COMB arm.
METHODS: The study will be a prospective, three-armed, randomized controlled trial conducted in Edmonton (coordinating center), Ottawa, and Vancouver. Participants will be 300 breast cancer survivors scheduled to receive adjuvant chemotherapy. All three exercise groups will be asked to perform supervised exercise 3 days/week for the length of their chemotherapy treatment. The STAN group will be asked to perform approximately 500 kilocalories/week of self-selected aerobic activities (e.g., treadmill, cycle ergometer, elliptical). This arm of the trial is considered standard care based on the emerging consensus of recent systematic reviews and recommendations from major cancer agencies. The HIGH group will be asked to complete approximately 1,000 kilocalories/week of self-selected aerobic activities. The COMB group will be asked to complete 1,000 kilocalories/week split equally between aerobic and resistance exercise. The primary endpoint in the trial will be change in physical functioning between baseline and post intervention as assessed by the physical functioning subscale of the Short Form (SF) 36 scale. Secondary endpoints will include cardiorespiratory fitness (maximal treadmill test), muscular strength (8 repetition maximum tests), muscular endurance (standard load test at 50% of estimated baseline maximum), body composition (DEXA scans), psychological distress, sleep quality, exercise adherence, and chemotherapy completion rates.
RELEVANCE: An important issue for breast cancer survivors receiving chemotherapy is whether there is any advantage to increasing the volume of aerobic exercise or adding resistance exercise to a standard aerobic exercise program. If there is an advantage, then it is important that breast cancer survivors receive this optimal exercise prescription to maximize their ability to cope with their chemotherapy treatments and maintain their physical function and QoL during this difficult time.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Physical exerciseCombined Aerobic and Resistance Exercise Program: perform three exercise sessions per week consisting of about 25-30 minutes of aerobic exercise at a moderate-to-vigorous intensity as well as some weight training consisting of two sets of 8-12 repetitions of 9-10 different exercises. For the aerobic exercise, participant can choose from different exercise equipment such as a treadmill or stationary bicycle. |
| 2 | Active comparator | Behavioral: Physical exerciseModerate Aerobic Exercise Group: perform three exercise sessions per week consisting of about 25-30 minutes of aerobic exercise at a moderate-to-vigorous intensity. Again, participant can choose from different exercise equipment. |
| 3 | Experimental | Behavioral: Physical exerciseHigh Aerobic Exercise Group: perform three exercise sessions per week consisting of about 45-60 minutes of aerobic exercise at a moderate-to-vigorous intensity. Again, participant can choose from different exercise equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Physical exerciseperform exercise program 3 days per week and 5 minutes of warm-up and cool-down exercises before and after the main exercise component | Behavioural | 1, 2, 3 |
Primary outcome
Patient rated physical functioning
Time frame: at 8 weeks and 24 weeks
1 secondary outcome
Physical fitness, body composition, treatment completion rates, exercise adherence rates, adverse events
Time frame: at 8 weeks and 24 weeks
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 18 Jul 2016.
- 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 32059728An KY, Kang DW, Morielli AR, Friedenreich CM, Reid RD, McKenzie DC, Gelmon K, Mackey JR, Courneya KS. Patterns and predictors of exercise behavior during 24 months of follow-up after a supervised exercise program during breast cancer chemotherapy. Int J Behav Nutr Phys Act. 2020 Feb 14;17(1):23. doi: 10.1186/s12966-020-00924-9.
- Derived from this study: PubMed 26896305Courneya KS, Segal RJ, Vallerand JR, Forbes CC, Crawford JJ, Dolan LB, Friedenreich CM, Reid RD, Gelmon K, Mackey JR, McKenzie DC. Motivation for Different Types and Doses of Exercise During Breast Cancer Chemotherapy: a Randomized Controlled Trial. Ann Behav Med. 2016 Aug;50(4):554-63. doi: 10.1007/s12160-016-9782-z.
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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 Courneya, PhD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physical exercise in people with Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Jul 2016. 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 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?
Patient rated physical functioning (time frame: at 8 weeks and 24 weeks). 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 NCT00249015, which also lists 3 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 18 Jul 2016.