The goal of this clinical trial is to learn whether a physiotherapy-led exercise programme delivered during treatment before surgery (neoadjuvant therapy) for breast cancer can improve physical fitness, quality of life, and how well people cope with treatment. The study will also investigate whether blood and tumour markers, including microRNAs (small molecules that help regulate gene activity), together with information about the participant and the cancer itself (clinical information), can help predict how well patients respond to treatment.
The main questions this study aims to answer are:
* Does a structured physiotherapy-led exercise programme improve physical fitness, muscle strength, quality of life, and the ability to complete treatment? * Can blood and tumour markers, together with clinical information, help predict which patients will have the best response to treatment?
Researchers will compare participants who receive the physiotherapy-led exercise programme with participants who receive standard care to determine whether the exercise programme improves physical and patient-reported outcomes.
Participants will:
* Receive standard treatment before surgery for breast cancer. * Be randomly assigned to either a 14-week physiotherapy-led personalised exercise programme or standard care. * Provide blood and tumour tissue samples for research. * Complete physical assessments and questionnaires about their symptoms, physical function, and quality of life during treatment. * Be followed throughout treatment, surgery, and follow-up to assess treatment response and other health outcomes.
Age 18 years or older.
Histologically confirmed diagnosis of breast cancer.
Planned treatment with standard-of-care neoadjuvant systemic therapy.
Ability to provide written informed consent.
Inability to provide informed consent.
Inability to complete patient-reported outcome assessments.
Pregnancy.
Presence of any condition that, in the opinion of the treating clinician, would preclude participation in study procedures.
Parallel
Physiotherapist-Led Personalised Adaptive Exercise Programme
BehavioralA structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with standard neoadjuvant systemic therapy. The intervention includes supervised and home-based aerobic and resistance exercise with progression tailored according to participant fitness, treatment tolerance and clinical status.
Estimated VO2max
Change in aerobic capacity (i.e. VO2max) as estimated from 6 minute walk test, following the physiotherapist-led intervention
Pathological complete response (pCR)
Pathological complete response (pCR), defined as the absence of residual invasive cancer in the breast and axillary lymph nodes at definitive surgery following completion of neoadjuvant systemic therapy.
Muscle Strength
Change in muscle strength measured using estimated one-repetition maximum (1RM) between baseline and completion of the intervention.
Fatigue
Change in fatigue assessed using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire. FACT-F is a patient-reported measure of cancer-related fatigue. Total scores range from 0 to 52, with higher scores indicating less fatigue (i.e. better outcome).
Muscle endurance (lower body)
Change in muscle endurance measured using a squat test (as many squats as possible in one minute).
Muscle endurance (upper body)
Change in muscle endurance measured using a push up test (as many correctly performed push ups in a row as possible).
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National University of Ireland, Galway, Ireland
Lead sponsor
Galway University Hospitals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
