None listed
Conditions
Brief summary
The chemotherapy medications used for breast cancer treatment are important for achieving a cure but a potential side effect is that they can affect heart function. Current tools used to assess your heart function during and following breast cancer treatment cannot accurately predict those who will go on to develop heart problems. Aerobic fitness is an important predictor of outcomes in people with certain forms of heart disease, and having a particularly low level of aerobic fitness (termed functional disability) appears very closely linked with the risk of developing heart failure. Importantly, functional disability also reflects an exercise capacity that would limit your ability to perform basic activities of daily living such as walking briskly, climbing stairs or gardening. We are conducting a study which aims to identify how anthracycline chemotherapy affects your exercise capacity and risk of functional disability. We would also like to assess how the standard test used to measure your heart function at rest compares to state of the art MRI imaging of the heart in being able to predict your risk of becoming functionally disabled. Furthermore, we are testing whether exercise training during and following your chemotherapy is helpful in protecting against functional disability. Who is it for? You may be eligible to join this study if you are between the ages 40 and 75 years old, have been diagnosed with breast cancer and are scheduled for Anthracycline-based chemotherapy. What is involved? You will be participating in a randomised controlled research project. You will be randomly assigned to one of two groups (just like a coin toss); the control group which receives usual care for your breast cancer, or the exercise group which participates in a 12 month supervised exercise intervention plus usual care. You will have an equal chance of being randomised into either the exercise or usual care group. You will then undergo a series of assessments at the Baker Heart and Diabetes Institute within two weeks of starting your chemotherapy (Baseline), after finishing chemotherapy (4 months) and again at 12 months after starting chemotherapy. Each round of testing will be split across two days, and last between 1.5-3.5 hours each. This means you will visit the Baker Heart and Diabetes Institute on 6 occasions, totalling approximately 15 hours. The testing sessions will include assessment of your heart function, exercise capacity, body composition, muscle strength/function, cognitive function and quality of life. The exercise program will consist of three to four sessions 60-minute exercise sessions per week of moderate-high intensity endurance (i.e cycling, walking, jogging) and resistance exercise aimed at improving your heart and muscle function. The training program will be prescribed by an Accredited Exercise Physiologist (AEP) who is experienced in prescribing exercise for individuals undergoing cancer treatment.
Interventions
Exercise Training:
The exercise training will consist of three phases: Phase 1 (exercise during chemotherapy: 4 months), Phase 2 (exercise rehabilitation following chemotherapy: 2 months) and Phase 3 (a step-down maintenance program: 6 months).
Phase 1 (Structured Exercise During Anthracycline Chemotherapy, 0-4 months):
Patients will be provided with an individualised training program in which they will be prescribed three 60-minute sessions of structured exercise per week at a local health and
Exercise Training: The exercise training will consist of three phases: Phase 1 (exercise during chemotherapy: 4 months), Phase 2 (exercise rehabilitation following chemotherapy: 2 months) and Phase 3 (a step-down maintenance program: 6 months). Phase 1 (Structured Exercise During Anthracycline Chemotherapy, 0-4 months): Patients will be provided with an individualised training program in which they will be prescribed three 60-minute sessions of structured exercise per week at a local health and fitness centre throughout the Melbourne metropolitan region and supervised by qualified exercise trainers. Exercise training will be prescribed by an Accredited Exercise Physiologist (AI Foulkes) and will include a brief warm-up and cool-down, moderate-continuous (60-80% maximal capacity) progressing to high-intensity interval training (HIIT) of approximately 4 x 4 minutes of cycling at >80% of maximal capacity separated by 2 minutes of active recovery, and 20-25 minutes of progressive resistance training consisting of 5-6 exercises targeting major muscle groups. Participants will perform 1-2 sets at 55-85% of their 1 repetition max (RM; equivalent to 8-15 RM). Exercise volume will be increased by 2-10% (via increases in exercise intensity and/or duration) per week with the exception of each week of chemotherapy administration. A 5-10% reduction in exercise volume will be scheduled for the week following chemotherapy administration individualised to each participant based on their heart rate reserve and rating of perceived exertion responses to exercise. This allows for increased recovery whilst participant symptoms are at their peak. Phase 2 (Structured Exercise Rehabilitation Following Anthracycline Chemotherapy): Participants will be continue with structured exercise training for a further 2 months following the completion of anthracycline chemotherapy. This will consist of two supervised sessions consisting of HIIT and the progressive resistance training as outlined above, and two sessions of moderate-intensity continuos training (45-60 minutes at 60-70% VO2peak) being performed by the participants without supervision. Unsupervised sessions will be performed at a local health and fitness centre (YMCA) or as a home-based exercise session. During the supervised sessions, participants will receive feedback and guidance on structuring and performing their independent exercise sessions in order to increase their self-efficacy towards exercise. There will also be an emphasis on motivational interviewing and goal setting to assist participants in incorporating a regular exercise routine into their lifestyle and to assist in the transition to phase 3 of the exercise program. Phase 3 (Step-down Maintenance Program, 6-12 Months): Participants will be provided with ongoing support for the final 6 months of the study via the prescription of a structured, individualised program for the subject to complete in an unsupervised environment, along with fortnightly telephone- and weekly text reminders. This program will consist of continued aerobic and resistance exercises focused on maintaining improvements in fitness, strength and physical function obtained in phase 1 and 2. Participants will attend up to five 60-minute supervised sessions in order to discuss their progress and update their training program. The frequency of these sessions will be determined in consultation with each participant based on their personal goals and confidence in performing exercise independently. In addition to their five supervised sessions, participants will also receive remote feedback on their training program via an online exercise prescription platform (Physitrack®). Participants will be provided with written feedback by their trainer each week, however participants have the ability to send direct messages to the trainer regarding any queries or issues related to the exercise program that require more immediate follow-up. Resistance exercises will be prescribed and monitored via the Physitrack® online patient engagement platform. Participants will be provided with wrist-worn heart rate monitors, which will be used to prescribe and monitor adherence to the aerobic exercise prescription remotely.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Women aged 40-75 years who have been diagnosed with breast cancer and are scheduled to undergo anthracycline-based chemotherapy will be eligible to participate in the study. All eligible participants must also obtain medical approval from their physician before participating.
Exclusion criteria
Participants will be excluded if they (1) have known structural heart disease (such as symptomatic ischemic heart disease, significant valvular disease or inherited cardiomyopathies), (2) have contraindications to the CMR procedure (pacemakers, implanted metallic foreign body or device), (3) have the presence of any serious contraindication or uncontrolled medical condition that would limit participation in the exercise program, (4) an inability to complete questionnaires in english language or (5) significant cognitive impairment.
Outcome results
None listed