Breast CancerCORENCT05522959
Cardio-Oncology Rehabilitation Exercise
An observational study of Breast Cancer, run by University of Toronto at 1 site in Canada.
Trial summary
Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Female early-stage breast cancer survivors.
Who may be able to join
- History of early-stage breast cancer (I-III)
- Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
- Able to communicate in English
Who cannot join
- Pregnancy
- Metastatic disease (Stage IV)
- Unable or unwilling to complete cardiopulmonary exercise test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario
Paul Oh, MD, Paul.Oh@uhn.ca
About this study
Official title: A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)
Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.
- Conditions
- Breast Cancer
- Keywords
- Cardiac Rehabilitation, Cardio-oncology, Cardiometabolic Health, Cardiovascular Disease Risk
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Fitness
VO2peak assessed using cardiopulmonary exercise test
Measured: post-intervention (16 weeks)
Secondary outcomes (11)
Visceral adipose tissue
Measured only in a subset (n=30) of participants via 1.5T MRI.
Measured: post-intervention (16 weeks)
Left ventricular ejection fraction
Measured only in a subset (n=30) of participants via 1.5T MRI.
Measured: post-intervention (16 weeks)
Native myocardial T1 time
Measured only in a subset (n=30) of participants via 1.5T MRI.
Measured: post-intervention (16 weeks)
Left ventricular mass
Measured only in a subset (n=30) of participants via 1.5T MRI.
Measured: post-intervention (16 weeks)
lipid profile
Assessed via fasting blood draw
Measured: post-intervention (16 weeks)
Fasting glucose
Assessed via fasting blood draw
Measured: post-intervention (16 weeks)
hemoglobin A1c
Assessed via fasting blood draw
Measured: post-intervention (16 weeks)
Cancer-specific, health-related quality of life
Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 108, with higher score representing better quality of life.
Measured: post-intervention (16 weeks)
Depressive symptoms
Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms.
Measured: post-intervention (16 weeks)
Psychosocial Stress
Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress.
Measured: post-intervention (16 weeks)
Cancer-related fatigue
Fatigue sub-scale of the Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 52, with higher score representing less fatigue.
Measured: post-intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start14 Mar 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
- Investigators
- Amy Kirkham, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522959
- Sponsor's protocol ID
- 19-5080
- Acronym
- CORE
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)
- ClinicalTrials.gov ID
- NCT05522959
- Acronym / sponsor ID
- CORE / 19-5080
- Conditions
- Breast Cancer
- Keywords
- Cardiac Rehabilitation, Cardio-oncology, Cardiometabolic Health, Cardiovascular Disease Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Aug 2022 (actual)
- 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.
Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female early-stage breast cancer survivors.
Key inclusion criteria (3 listed)
- History of early-stage breast cancer (I-III)
- Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
- Able to communicate in English
Key exclusion criteria (3 listed)
- Pregnancy
- Metastatic disease (Stage IV)
- Unable or unwilling to complete cardiopulmonary exercise test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiopulmonary Fitness
Time frame: post-intervention (16 weeks)
VO2peak assessed using cardiopulmonary exercise test
11 secondary outcomes
Visceral adipose tissue
Time frame: post-intervention (16 weeks)
Left ventricular ejection fraction
Time frame: post-intervention (16 weeks)
Native myocardial T1 time
Time frame: post-intervention (16 weeks)
Left ventricular mass
Time frame: post-intervention (16 weeks)
lipid profile
Time frame: post-intervention (16 weeks)
Fasting glucose
Time frame: post-intervention (16 weeks)
hemoglobin A1c
Time frame: post-intervention (16 weeks)
Cancer-specific, health-related quality of life
Time frame: post-intervention (16 weeks)
Depressive symptoms
Time frame: post-intervention (16 weeks)
Psychosocial Stress
Time frame: post-intervention (16 weeks)
Cancer-related fatigue
Time frame: post-intervention (16 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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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.
Amy Kirkham, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Toronto 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?
The sponsor lists 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy A Kirkham, PhD ((416) 946-4069, amy.kirkham@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Fitness (time frame: post-intervention (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.