Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-25
Brief Title:
Exercise for Ameliorating Chemotherapy Cardiotoxicity
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Queens 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 2daysweek 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 complyadhere This will inform a larger study which will assess if exercise maintains heart and vessel health 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 Queens 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 2daysweek 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 complyadhere 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None