Clinical trial · Interventional
IRELAND Trial: A Translational Biomarker and Exercise Study During Neoadjuvant Breast Cancer Therapy
Investigating Molecular and Clinical pREdictors of Outcome foLlowing neoadjuvAnt Therapy in Breast caNcer Dynamics (IRELAND Trial): A Translational Study With an Embedded Physiotherapist-Led Exercise Randomised Controlled Trial
- 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physiotherapist-Led Personalised Adaptive Exercise Programme | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Physiotherapist-Led Exercise Programme
- description
- Participants allocated to the experimental arm will receive a structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with standard neoadjuvant systemic therapy. The programme includes supervised and home-based aerobic and resistance exercise, with progression tailored to participant clinical status and treatment tolerance.
- interventionNames
- Behavioral: Physiotherapist-Led Personalised Adaptive Exercise Programme
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.
Primary outcomes (2)
- measure
- Estimated VO2max
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 2. Histologically confirmed diagnosis of breast cancer. 3. Planned treatment with standard-of-care neoadjuvant systemic therapy. 4. Ability to provide written informed consent. 5. Ability to partake in 14-week physiotherapist-led personalised adaptive exercise programme. 6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2. Exclusion Criteria: 1. Inability to provide informed consent. 2. Inability to complete patient-reported outcome assessments. 3. Pregnancy. 4. Presence of any condition that, in the opinion of the treating clinician, would preclude participation in study procedures. 5. Inability to partake in 14-week physiotherapist-led personalised adaptive exercise programme.
References
Publications (0)
Data not yet available