Exercise for Ameliorating Chemotherapy Cardiotoxicity

NCT06595316 | Not Yet Recruiting

• 1 other identifier: RS216 - 338687
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiotoxicity

Keywords

exercise; cardiotoxicity; exercise oncology; breast cancer

Outcome Measures

Primary Outcomes (11)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Quantitative and Qualitative Feasibility Log of Adverse Events of Participants

  To assess the feasibility of Adverse Events of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative and qualitative information regarding details of reactions to the exercise intervention like any cardiorespiratory complications, musculoskeletal injury or pain or discomfort.

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

• Quantitative Feasibility Checklist of Fidelity

  To assess the feasibility of Intervention Fidelity of delivering the protocol to breast cancer patients undergoing chemotherapy. This will be measured by Checklist of Fidelity e.g., if exercise sessions start on time, if patients complete the exercise session, if exercise sessions finish on time. Every item is rated on binary metric where "0" equates No and "1" equates yes.

  Fidelity will be recorded will be recorded during the weeks of exercise intervention, (18 weeks).

• Quantitative Feasibility Log of Adherence of Participants

  To assess the feasibility of Adherence 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 percentage of classes attended out of the sessions planned.

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

• Quantitative Feasibility Log of Compliance (duration) of Participants

  To assess the feasibility of Compliance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by the total number of minutes per exercise session achieved over all weeks of the exercise programme (duration); this quantitative information will be recorded at the Researchers Log.

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

• Quantitative Feasibility Log of Compliance (intensity) of Participants

  To assess the feasibility of Compliance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by the intensity achieved by the patients during the intervention (%HRR); this quantitative information will be recorded at the Researchers Log.

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

• Quantitative Feasibility Log of Completion (retention) of Participants

  To assess the feasibility of Completion (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 regarding the percentage of patients continuously attending and assessed at follow-up.

  Completion (retention) will be recorded through study completion, an average of 15 months.

• Qualitative Feasibility Log of Perception and experience of Participants

  To assess the feasibility of the exercise protocol to breast cancer patients undergoing chemotherapy, Perception and experience of participants, as well as details of the impact this intervention had on their lives.will be recorded through an open-ended questions questionnaire. Information obtained will be recorded on the Researches Log.

  Perception and experience of Participants will be recorded within one week after the last exercise session of each patient has taken place.

Secondary Outcomes (12)

• Echocardiographic scans - Left Ventricular Ejection Fraction (LVEF)

  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)

  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.

  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)

  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)

  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).

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

For this group (N=15) the intervention will consist of two supervised sessions per week, which include aerobic and resistance exercise, carried out as previuosly described.

Other: Exercise intervention group

Control group (usual care)

NO INTERVENTION

For the Control group or usual care (N=15), there will be no exercise sessions. Although, the same assessments as the intervention group will be carried out, at the same time-points.

Interventions

Exercise intervention group OTHER

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.

Exercise intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with cognitive disorders
• Cancer metastases
• Uncontrolled or serious illnesses that might hamper patients' capacity of exercising

Sponsors & Collaborators

• University of Hull: lead
• Hull University Teaching Hospitals NHS Trust: collaborator

MeSH Terms

Conditions

Cardiotoxicity; Motor Activity; Breast Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Samantha Ruilova Medina

CONTACT

+447466119052; s.e.ruilova-2019@hull.ac.uk

John Saxton, PhD

CONTACT

john.saxton@hull.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share