An interventional study of Physiotherapist-Led Personalised Adaptive Exercise Programme in Breast Neoplasms and Breast Cancer, sponsored by National University of Ireland, Galway, Ireland. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by National University of Ireland, Galway, Ireland · Not applicable, Interventional, and Supportive care
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:
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:
Breast cancer is a heterogeneous disease with substantial variability in response to neoadjuvant systemic therapy despite advances in systemic treatment. Although pathological complete response (pCR) is an established surrogate marker of treatment efficacy in selected breast cancer subtypes, there remains a need for improved molecular and clinical predictors of treatment response, disease progression, and long-term outcomes. Circulating and tumour-derived microRNAs (miRNAs) have emerged as promising translational biomarkers because of their biological stability and potential to reflect tumour biology and dynamic changes during therapy.
The IRELAND Trial is designed to prospectively integrate molecular, clinical, imaging, physiological, and patient-reported data collected throughout the neoadjuvant treatment pathway. The study aims to develop a comprehensive understanding of factors associated with treatment response and patient outcomes by combining biological specimen analysis with longitudinal clinical assessment. Blood and tumour tissue specimens will be collected at predefined time points for translational analyses, while radiological, pathological, and patient-reported outcome data will be collected prospectively using standardised assessment methods.
Embedded within the translational cohort is a randomised controlled trial (CanReAct Trial) evaluating a structured 14-week physiotherapist-led personalised adaptive exercise programme delivered concurrently with standard-of-care neoadjuvant systemic therapy. Participants will be randomised to receive either the exercise intervention or standard care. The intervention is intended to optimise physical function during treatment and evaluate its effects on functional capacity, treatment tolerance, quality of life, and other patient-centred outcomes without altering oncological management.
By integrating translational biomarker research with a structured supportive care intervention, the IRELAND Trial seeks to generate evidence that may improve prediction of treatment response while informing future personalised management strategies for patients undergoing neoadjuvant therapy for breast cancer.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 250 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National University of Ireland, Galway, Ireland is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Physiotherapist-Led Personalised Adaptive Exercise Programme
Participants will receive standard neoadjuvant systemic therapy and routine clinical care without the structured physiotherapist-led exercise programme.
A 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
Time frame: Baseline and 14 weeks (end of 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.
Time frame: 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.
Time frame: Baseline and Week 14
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).
Time frame: Baseline and Week 14
Muscle endurance (lower body)
Change in muscle endurance measured using a squat test (as many squats as possible in one minute).
Time frame: Baseline and Week 14
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).
Time frame: Baseline and Week 14
Participant retention rate
Proportion of enrolled participants who complete the 14-week physiotherapist-led exercise programme and remain in the study until completion of the intervention.
Time frame: Throughout the 14-week intervention
Adherence
Adherence to the physiotherapy intervention assessed by attendance rate and exercise log compliance.
Time frame: Throughout the 14-week intervention
Exercise-related adverse events
Incidence and severity of adverse events attributable to the exercise intervention.
Time frame: Throughout the 14-week intervention
Disease-free survival
Time from surgery to disease recurrence or death from any cause.
Time frame: Up to 10 years after surgery (or according to study follow-up)
Circulating and tumour microRNA expression
Identification of circulating and tumour microRNA expression profiles associated with pathological and radiological response to neoadjuvant therapy.
Time frame: Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Longitudinal circulating microRNA expression
Longitudinal changes in circulating microRNA expression during neoadjuvant therapy and follow-up.
Time frame: Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
MicroRNA expression: Clinicopathological associations
Associations between microRNA expression profiles and clinicopathological characteristics, including tumour subtype, stage, hormone receptor status, HER2 status and treatment variables.
Time frame: After completion of 12-month post-surgery follow-up.
MicroRNA expression: Genomic and radiomic correlations
Correlation of microRNA signatures with genomic recurrence scores and radiomic imaging features.
Time frame: After completion of 12-month post-surgery follow-up.
Lean body mass
Change in lean body mass (kg) measured using body composition analysis.
Time frame: Baseline and Week 14
Hydration
Change in total body water (L) measured using body composition analysis
Time frame: Baseline and Week 14
Fat mass
Change in fat mass (kg) measured using body composition analysis.
Time frame: Baseline and Week 14
Body weight
Change in body weight, measured in kilograms (kg).
Time frame: Baseline and Week 14
Body mass index
Change in body mass index (BMI), calculated as weight in kilograms divided by height in metres squared (kg/m²).
Time frame: Baseline and Week 14
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. For the Global Health Status/Quality of Life and functional scales, higher scores indicate better quality of life/functioning. For the symptom scales, higher scores indicate greater symptom burden (worse outcome).
Time frame: Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 45 (EORTC QLQ-BR45)
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 45 (EORTC QLQ-BR45). Scores range from 0 to 100. For the functional scales, higher scores indicate better functioning. For the symptom scales, higher scores indicate greater symptom burden (worse outcome).
Time frame: Baseline, start of Cycle 3 chemotherapy, after completion of the 14-week physiotherapy programme, at surgery, 4 weeks post-surgery, and 12 months post-surgery (each cycle is 2-4 weeks).
No study locations are listed for this record.
Plan to share: Undecided — The individual participant data (IPD) sharing plan has not yet been finalized. Any future data sharing will be considered in accordance with institutional policies, participant consent, applicable ethical approvals, and data protection regulations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University of Ireland, Galway, Ireland