Clinical trial · Interventional
Exercise for Ameliorating Chemotherapy Cardiotoxicity
A Randomized Controlled Feasibility Trial of a Vigorous Intensity Aerobic Exercise and Resistance Training Intervention for Mitigating Chemotherapy Cardiotoxicity in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise intervention group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise intervention group
- description
- 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.
- interventionNames
- Other: Exercise intervention group
- type
- NO_INTERVENTION
- label
- Control group (usual care)
- description
- 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.
Primary outcomes (11)
- measure
- Quantitative Feasibility Log of Eligibility of Participants.
- timeFrame
- Eligibility will be recorded through study completion, an average of 15 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available