Clinical trial NCT06595316: Exercise for Ameliorating Chemotherapy Cardiotoxicity
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiotoxicity
Keywords: exercise
cardiotoxicity
exercise oncology
breast cancer
Lead sponsor: University of Hull
Sponsor class: OTHER
Collaborators: name: Hull University Teaching Hospitals NHS Trust
First posted: 2024-09-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants recruited will be cancer patients who attend to the Queen's Centre for Oncology and Haematology at Castle Hill Hospital, whose confirmed diagnosis is ER+ HER2- breast cancer, and whose chemotherapy regimen is 3 cycles of epirubicin and cyclophosphamide (EC) followed by 3 cycles docetaxel over a period of 18 weeks. They will be identified, screened and selected according to the study's inclusion and exclusion criteria, and then approached by their Consultant Clinical Oncologist in charge and/or the researcher. Patients will be offered the opportunity to be part of the study. Individuals will only participate if they have provided informed consent.

Participants will be randomly allocated in a 1:1 ratio, either to intervention group, or the control group (usual care) by an unrestricted simple random sampling technique, until the maximum number of participants has been reached, which is a total of 15 individuals per group over a period of maximum 15 months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Quantitative Feasibility Log of Eligibility of Participants.
timeFrame: Eligibility will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Log of Recruitment of Participants
timeFrame: Recruitment will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Log of Retention of Participants
timeFrame: Retention will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Log of Attendance of Participants
timeFrame: Retention will be recorded through study completion, an average of 15 months.
measure: Quantitative and Qualitative Feasibility Log of Adverse Events of Participants
timeFrame: Adverse Events will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Checklist of Fidelity
timeFrame: Fidelity will be recorded will be recorded during the weeks of exercise intervention, (18 weeks).
measure: Quantitative Feasibility Log of Adherence of Participants
timeFrame: Adherence will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Log of Compliance (duration) of Participants
timeFrame: Compliance will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Log of Compliance (intensity) of Participants
timeFrame: Compliance will be recorded through study completion, an average of 15 months.
measure: Quantitative Feasibility Log of Completion (retention) of Participants
timeFrame: Completion (retention) will be recorded through study completion, an average of 15 months.
measure: Qualitative Feasibility Log of Perception and experience of Participants
timeFrame: Perception and experience of Participants will be recorded within one week after the last exercise session of each patient has taken place.
Secondary outcomes:
measure: Echocardiographic scans - Left Ventricular Ejection Fraction (LVEF)
timeFrame: 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).
measure: Echocardiographic scans - Peak systolic global longitudinal strain (GLS)
timeFrame: 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).
measure: Blood-borne biomarkers - Concentration of B-type natriuretic peptide (NT-ProBNP), Troponin I & T in blood samples.
timeFrame: 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).
measure: 12-lead Electrocardiogram (ECG)
timeFrame: 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).
measure: Brachial artery flow-mediated dilation (FMD)
timeFrame: 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).
measure: Aortic Pulse Wave Velocity (PWV)
timeFrame: 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).
measure: The six Minute Walking Test (6MWT)
timeFrame: 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).
measure: Hand-grip Dynamometry
timeFrame: 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).
measure: 30 seconds Sit-to-stand Tests
timeFrame: 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).
measure: The Functional Assessment of Chronic Disease Therapy
timeFrame: 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)
measure: The Functional Assessment of Cancer Therapy - Breast
timeFrame: 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)
measure: The 7-day Physical Activity Recall Scale
timeFrame: 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)
Other outcomes:
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