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

NCT03089502 | Terminated

• 1 other identifier: CORE
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Left Ventricular Dysfunction; Heart Failure, Systolic

Keywords

Exercise; Cardiac Rehabilitation; Breast Caner; Left Ventricular Dysfunction; Trastuzumab; Anthracyclines

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary Fitness

  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).

  Baseline and 12 weeks

Secondary Outcomes (7)

• Cardiovascular Risk Profile

  Baseline and 12 weeks

• Cardiac Function and Structure at Rest

  Baseline and 12 weeks.

• Cardiac Function During Stress (Exercise)

  Baseline and 12 weeks

• Endothelial Function

  Baseline and 12 weeks

• Arterial Stiffness

  Baseline and 12 weeks

Other Outcomes (1)

• Exercise Adherence

  Throughout the exercise training program (up to 12 weeks)

Study Arms (2)

Exercise Rehabilitation

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Exercise Rehabilitation OTHER

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.

Exercise Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• MSH-UHN AMO Innovation Fund: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Ventricular Dysfunction, Left; Heart Failure, Systolic; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Heart Failure; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Paul Oh, MD,MSc

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 24, 2017
• Study Start: April 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)