Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06595316
NA

Exercise for Ameliorating Chemotherapy Cardiotoxicity

Sponsor: University of Hull

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-10-15

Completion Date

2025-12-01

Last Updated

2024-09-19

Healthy Volunteers

No

Conditions

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 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.