Exercise for Ameliorating Chemotherapy Cardiotoxicity

NCT ID: NCT06595316

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-12-01

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.

Conditions

Cardiotoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise intervention group

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.

Group Type: EXPERIMENTAL

Exercise intervention group

Intervention Type: 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.

Control group (usual care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Hull

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Samantha Ruilova Medina

Role: CONTACT

s.e.ruilova-2019@hull.ac.uk

+447466119052

John Saxton, PhD

Role: CONTACT

john.saxton@hull.ac.uk

Other Identifiers

RS216 - 338687

Identifier Type: -

Identifier Source: org_study_id