EXERCISE FOR AMELIORATING CHEMOTHERAPY CARDIOTOXICITY
Research type
Research Study
Full title
A RANDOMIZED CONTROLLED FEASIBILITY TRIAL OF A VIGOROUS INTENSITY AEROBIC EXERCISE AND RESISTANCE TRAINING INTERVENTION FOR MITIGATING CHEMOTHERAPY CARDIOTOXICITY IN BREAST CANCER PATIENTS
IRAS ID
338687
Contact name
Samantha Ruilova
Contact email
Sponsor organisation
University of Hull
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 17 days
Research 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.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
24/YH/0225
Date of REC Opinion
2 Dec 2024
REC opinion
Further Information Favourable Opinion