Exercise for Ameliorating Chemotherapy Cardiotoxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise intervention group.
- Who it may be relevant to
- Registry conditions: Cardiotoxicity. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Feasibility Trial of a Vigorous Intensity Aerobic Exercise and Resistance Training Intervention for Mitigating Chemotherapy Cardiotoxicity in Breast Cancer Patients
Overview
Chemotherapy is a common treatment for breast cancer but can damage the heart and blood vessels. Exercise, such as cycling, may stop chemotherapy from damaging the heart and blood vessels. Before the effects of exercise on the heart and blood vessels can be fully determined in a large trial, a small trial must first be carried out to assess if exercise can be included safely and practically during chemotherapy treatment. This study is designed so that a group of breast cancer patients will exercise during their chemotherapy treatment, whilst another group does not exercise. Participants will be breast cancer patients from the Queen's Centre for Oncology and Haematology at Castle Hill Hospital. Suitable patients will be identified and approached by their Consultant Clinical Oncologist. If patients decide to take part, they will be randomly placed into groups ('exercise' or 'usual care') before starting chemotherapy. The exercise group will exercise for 50-60 minutes 2days/week in the Cardiac Rehabilitation Gym at Castle Hill Hospital during their chemotherapy treatment. Exercise will be supervised, consisting of repeated 5-minute bouts of high intensity cycling plus strength training. The usual care group will be given their normal chemotherapy only (no exercise). Both groups will take part in tests before they begin chemotherapy treatment. Tests assess heart and blood vessel health, fitness, strength, fatigue, and quality of life. The same tests will happen again during the intervention, after the intervention and 3-months later. Participants will also have to complete questionnaires to give their opinion of the study. The main point of the study is to determine if the exercise and tests are received well by patients, if recruitment is good, and if patients comply/adhere. This will inform a larger study which will assess if exercise maintains heart and vessel health during chemotherapy treatment.
Detailed description
Exercise has been shown to have benefits within cardio-oncology settings and evidence supports the use of exercise as a cardioprotective method in breast cancer. Several studies demonstrate evidence for positive effects of aerobic and resistance exercise to improve or alleviate the usual effects of chemotherapy on the heart and blood vessels in breast cancer. Despite the existing evidence that shows promising outcomes regarding exercise interventions for breast cancer patients undergoing chemotherapy who are at risk of developing cardiotoxicity due to treatment there is still insufficient evidence for exercise to be prescribed to this population as an adjuvant instrument to reduce cardiotoxicity.
Through this study we aim to build on the evidence base with the purpose of encouraging practice towards this approach. However, before a large definitive randomized controlled trial (RCT) can be conducted, the first step is to assess the feasibility of a high intensity exercise intervention during chemotherapy for breast cancer. This will inform the design of a large RCT which will determine the cardio-protective effects of the exercise intervention.
As this is a feasibility study the main outcome is to find out the practicalities of delivering the proposed exercise intervention in a healthcare setting by collecting information regarding eligibility, recruitment rates, retention, adherence, fidelity, and adverse events.
Secondary outcome measures will provide information about cardiac function, cardiovascular toxicity and inflammation, electrical activity of the heart, vascular function, functional capacity, muscle strength, fatigue, quality of life, and finally experiences and perceptions of patients after participating in the intervention.
Interventions
- Other Exercise intervention group
Exercise will consist of two supervised sessions per week. Starting with vital signs monitoring (blood pressure, temperature, blood oxygen levels, heart rate). The aerobic component consists of a 5-minute warm-up, followed by 3 bouts of 4-minute cycling at an intensity of 60-65% HRR, with 2-minute active recovery periods in between and a 5-minute cool down. The goal is to increase up to an intensity of around 80%-85% HRR by weeks 16 to 18. Intensity will be monitored with The Borg Rating Scale
Primary outcome measures
- Quantitative Feasibility Log of Eligibility of Participants. [Time frame: Eligibility will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Log of Recruitment of Participants [Time frame: Recruitment will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Log of Retention of Participants [Time frame: Retention will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Log of Attendance of Participants [Time frame: Retention will be recorded through study completion, an average of 15 months.]
- Quantitative and Qualitative Feasibility Log of Adverse Events of Participants [Time frame: Adverse Events will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Checklist of Fidelity [Time frame: Fidelity will be recorded will be recorded during the weeks of exercise intervention, (18 weeks).]
- Quantitative Feasibility Log of Adherence of Participants [Time frame: Adherence will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Log of Compliance (duration) of Participants [Time frame: Compliance will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Log of Compliance (intensity) of Participants [Time frame: Compliance will be recorded through study completion, an average of 15 months.]
- Quantitative Feasibility Log of Completion (retention) of Participants [Time frame: Completion (retention) will be recorded through study completion, an average of 15 months.]
Secondary outcome measures (12)
- Echocardiographic scans - Left Ventricular Ejection Fraction (LVEF) [Time frame: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- Echocardiographic scans - Peak systolic global longitudinal strain (GLS) [Time frame: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- Blood-borne biomarkers - Concentration of B-type natriuretic peptide (NT-ProBNP), Troponin I & T in blood samples. [Time frame: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- 12-lead Electrocardiogram (ECG) [Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- Brachial artery flow-mediated dilation (FMD) [Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- Aortic Pulse Wave Velocity (PWV) [Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- The six Minute Walking Test (6MWT) [Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- Hand-grip Dynamometry [Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- 30 seconds Sit-to-stand Tests [Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).]
- The Functional Assessment of Chronic Disease Therapy [Time frame: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)]
- The Functional Assessment of Cancer Therapy - Breast [Time frame: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)]
- The 7-day Physical Activity Recall Scale [Time frame: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)]
Eligibility criteria
Inclusion criteria
- Females between 18 to 75 years old.
- Confirmed early stage (I-III) ER+ HER2 - breast cancer diagnosis
- Undergoing adjuvant and neoadjuvant chemotherapy, consisting of epirubicin and cyclophosphamide (EC) followed by Docetaxel.
- No contraindications to engage in physical activity.
- Capable of giving informed consent.
- Patients able to understand and communicate in English language
Exclusion criteria
- Participants with cognitive disorders
- Cancer metastases
- Uncontrolled or serious illnesses that might hamper patients' capacity of exercising
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06595316 · RS216 - 338687