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Efficacy of Cardio-Oncology Rehabilitation Exercise for Women With Breast Cancer and Treatment Related Cardiotoxicity (CORE)

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ClinicalTrials.gov Identifier: NCT03089502
Recruitment Status : Terminated (Limited recruitment)
First Posted : March 24, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
MSH-UHN AMO Innovation Fund
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Breast cancer is the leading cause of cancer among Canadian women with nearly 26,000 new cases diagnosed each year. Fortunately, advancements in diagnostic tools and curative treatments have significantly improved overall survival. However, the development of cardiac toxicity (including asymptomatic and symptomatic heart failure) associated with use of anthracycline containing chemotherapy and targeted therapies including trastuzumab limits improvements in survival for women with breast cancer. Cardiac toxicity is a life threatening complication that leads to reduced physical functioning and quality of life. The increased risk is associated with shared risk factors among cancer and heart failure and the direct influence of cancer therapy on the cardiovascular system. Cardiac rehabilitation (CR) (including exercise training and education/counselling) has been shown to improve health outcomes, reduce heart failure related hospitalizations and modestly improve mortality among individuals with non-treatment related heart failure and may benefit women with breast cancer and treatment related cardiac toxicity (BC-CT). Therefore, this single centre, randomized control trial aims to determine if participation in an exercise based CR program can improve cardiorespiratory fitness, cardiovascular function/structure and health, and quality of life among women with BC-CT.

Condition or disease Intervention/treatment Phase
Breast Cancer Left Ventricular Dysfunction Heart Failure, Systolic Other: Exercise Rehabilitation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of the Efficacy of a Cardio-Oncology Rehabilitation Exercise Program to Improve Cardiorespiratory Fitness in Women With Breast Cancer and Treatment Related Cardiotoxicity (CORE Study).
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Rehabilitation
The intervention group will participate in the exercise rehabilitation program for a total of 12 weeks. This includes performing aerobic training five times per week and resistance training two to three times per week. Participants will also be expected to attend the education sessions following their supervised exercise rehabilitation sessions each week.
Other: Exercise Rehabilitation
The intervention will consist of a walking or biking program performed at an intensity of 60-80% of VO2peak, progressing to a minimum of 150 minutes/week. Each session will include a warm up and cool down. One weekly exercise session will be supervised and participants will be expected to complete four additional aerobic training sessions at home or in the community each week. Resistance training will be introduced during the 4th week of the program and will consist of 10 exercises targeting all major muscle groups. One weekly resistance training session will be supervised following the aerobic training, and participants will be expected to complete one to two additional sessions at home or in the community each week. Weekly education sessions will follow the supervised exercise session.

No Intervention: Usual Care
Participants in the control group will be encouraged to continue with their regular physical activity routine and will receive regular standard of care by their Cardiologist and Oncologist.



Primary Outcome Measures :
  1. Cardiopulmonary Fitness [ Time Frame: Baseline and 12 weeks ]
    A cardiopulmonary exercise test will be completed following the Bruce or modified Bruce protocol. Breath-by-breath gas samples will be collected and averaged over a 20-second period using a calibrated metabolic cart (Vmax Encore, SensorMedics, Yoba Linda, CA).


Secondary Outcome Measures :
  1. Cardiovascular Risk Profile [ Time Frame: Baseline and 12 weeks ]
    This will be assessed using a standard blood requisition blood form including measurement of lipids, cholesterol, and triglyceride levels. Anthropometrics including body mass index, waist circumference, body fat percent and hemodynamic profiles including heart rate, systolic and diastolic blood pressure values (resting and during exercise) will also be collected.

  2. Cardiac Function and Structure at Rest [ Time Frame: Baseline and 12 weeks. ]
    2D Echocardiography will be used for the measurement of left ventricular volumes, cardiac output, stroke volume, left ventricular ejection fraction, diastolic function, left ventricular wall thickness and left ventricular cavity size. Strain and Strain Rate via 2D-Speckle tracking imaging will also be collected at rest to assess cardiac function.

  3. Cardiac Function During Stress (Exercise) [ Time Frame: Baseline and 12 weeks ]
    Exercise will be performed following a standardized stress echocardiography protocol. 2D-echocardiography assessments will be conducted at rest, during exercise and within 30 seconds of exercise completion.

  4. Endothelial Function [ Time Frame: Baseline and 12 weeks ]
    Endothelial dependant flow mediated dilation of the brachial artery will be assessed using a portable ultrasound unit (Vivid 9E GE Healthcare), and a 8-14-MHz transducer (GE Medical Systems Wauwatosa, WI USA).

  5. Arterial Stiffness [ Time Frame: Baseline and 12 weeks ]
    Arterial Stiffness will be measured by pulse-wave velocity (Sphygmocor® system).

  6. Autonomic Function [ Time Frame: Baseline and 12 weeks ]
    Baroreceptor sensitivity will be collected as a measure of autonomic function. Each participant will be secured with a three-lead ECG and finger plethysmography worn on the middle finger, while measures of a beat-by-beat blood pressure are recorded (Finapres; Ohmeda Inc, Englewood, CO).

  7. Quality of Life [ Time Frame: Baseline and 12 weeks ]

    The Kansas City Cardiomyopathy Questionnaire will be used to assess health related quality of life for heart failure.

    The FACT-B questionnaire will be used as a measurement of health related quality of life for individuals with breast cancer.



Other Outcome Measures:
  1. Exercise Adherence [ Time Frame: Throughout the exercise training program (up to 12 weeks) ]
    Adherence will be assessed using an attendance sheet for each the supervised sessions. If participants do not complete their target exercise prescription, the reasons will be recorded. The participants will also complete weekly exercise diaries at home each week and will be asked to record reasons for missed sessions or if they were unable to meet their exercise prescription. A step counter (PiezoRx®) that monitors the participants' moderate/vigorous activity time (>100 steps per minute) as well as bouts per week (greater than 10 minutes of moderate/vigorous activity) will also be recorded. These measurements will be used to confirm the reported exercise sessions to be completed at home each week.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with breast cancer (receptor status: human epidermal growth factor receptor (HER2+/-), Progesterone receptor, (PR+/-), estrogen receptor (ER+/-); Stage I-III)
  • Are 18 yrs. of age or older
  • A diagnosis of cardiac toxicity that occurred during treatment will be defined as a decrease from baseline in the left ventricular ejection fraction of >10 percentage points, to a value < 53% by 2D-echocardiography upon repeated measures or a diagnosis of heart failure which will be confirmed by the cardiologist upon cardiac evaluation
  • Currently undergoing known cardiotoxic agents including the HER2-antagonist trastuzumab and/or chemotherapy agents including doxorubicin and epirubicin

Exclusion Criteria:

  • Women who are pregnant
  • Treated with a left ventricular assistant device or a pacemaker.
  • Have metastatic disease
  • Previous exposure to anthracyclines, cytotoxic treatments or radiation preceding their breast cancer diagnosis
  • Unable to confirm a diagnosis of heart failure due to treatment for breast cancer upon cardiac evaluation by their Cardiologist
  • Myocardial infarction, complex arrhythmias, or unstable cardiac symptoms in the previous six weeks prior to study enrolment
  • Significant co-morbidities that limit their ability to perform exercise (i.e., severe peripheral artery disease, severe chronic obstructive pulmonary disease, musculoskeletal injury or stroke)
  • Contraindications to exercise training identified on their first cardiopulmonary assessment that do not subside prior to beginning the program including angina pectoris symptoms, light-headedness or dizziness with exercise, and resting blood pressure > 200mmHg systolic or >120mmHg diastolic blood pressure.
  • Contraindications to resistance training including increased eye pressures (> 20mmHg), untreated hernias, limitations due to surgery (lumpectomy/mastectomy) and potential musculoskeletal injuries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089502


Locations
Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
MSH-UHN AMO Innovation Fund
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Paul Oh, MD,MSc University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03089502     History of Changes
Other Study ID Numbers: CORE
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual data of the primary and secondary outcomes will be made available to other researchers as a supplementary file to be accompanied by any publications generated by this clinical trial. Individual data will also be made available upon request for research purposes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
Exercise
Cardiac Rehabilitation
Breast Caner
Left Ventricular Dysfunction
Trastuzumab
Anthracyclines

Additional relevant MeSH terms:
Breast Neoplasms
Heart Failure
Ventricular Dysfunction
Cardiotoxicity
Ventricular Dysfunction, Left
Heart Failure, Systolic
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries