About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants with cognitive disorders

Cancer metastases

Uncontrolled or serious illnesses that might hamper patients' capacity of exercising

Trial design

Design model

Parallel

Treatments tested in this trial

Exercise intervention group
Other intervention
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 of Perceived Exertion (RPE). The resistance component will consist of upper body and lower body exercises (door frame rows, wall push-ups, glute bridges, triceps lifts and squat to calf rise) starting on week one with a set of 12 repetitions of each exercise, with 2-minute recovery in between exercises aiming to increase the number of sets and reducing the number of repetitions.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Exercise intervention groupExperimental treatment 1 intervention

Group B: Control group (usual care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Quantitative Feasibility Log of Eligibility of Participants.

To assess the feasibility of Eligibility of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the number of patients able to take part of the study after shared characteristics as a population have been assessed.

Time frame

Eligibility will be recorded through study completion, an average of 15 months.

2

Quantitative Feasibility Log of Recruitment of Participants

To assess the feasibility of Recruitment of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information considering the number of randomized patients over the total number of months of recruitment time.

Time frame

Recruitment will be recorded through study completion, an average of 15 months.

3

Quantitative Feasibility Log of Retention of Participants

To assess the feasibility of Retention of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information where Retention will be assessed by the formula based on the number of participants at the end of the set time period divided by the number of patients participating at the start of the set time period and multiplied by 100.

Time frame

Retention will be recorded through study completion, an average of 15 months.

4

Quantitative Feasibility Log of Attendance of Participants

To assess the feasibility of Attendance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the number of sessions attended per each patient, throughout the program.

Time frame

Retention will be recorded through study completion, an average of 15 months.

Secondary outcomes

1

Echocardiographic scans - Left Ventricular Ejection Fraction (LVEF)

The Percentage of Left Ventricular Ejection Fraction (LVEF) will be measured as an outcome measure for cardiac function.

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).

2

Echocardiographic scans - Peak systolic global longitudinal strain (GLS)

The percentage of Peak systolic global longitudinal strain (GLS) will be measured as an outcome measure for cardiac function.

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).

3

Blood-borne biomarkers - Concentration of B-type natriuretic peptide (NT-ProBNP), Troponin I & T in blood samples.

B-type natriuretic peptide (NT-ProBNP), Troponin I \& T will be measured,these are blood markers of cardiovascular toxicity and inflammation.

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).

4

12-lead Electrocardiogram (ECG)

This assessment will help measure the electrical activity of the heart. Parameters considered will be: measurements (Heart Rate, PR Interval, QRS Duration, QT Interval, Frontal Plane QRS Axis), Rhythm (if normal or abnormal, P waves), Conduction (Normal Sino-atrial, Atrio-ventricular, and Intraventricular conduction, PR interval and QRS duration), Waveform Description, P Wave (P duration, P amplitude, Frontal plane P wave axis), QRS Complex (duration, amplitude, Frontal plane leads, Precordial leads), and ST Segment and T wave

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).

Locations

This trial has no locations.

Exercise for Ameliorating Chemotherapy Cardiotoxicity

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts