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IRELAND Trial: A Translational Biomarker and Exercise Study During Neoadjuvant Breast Cancer Therapy

NCT07799337 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-09-02

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Physiotherapist-Led Personalised Adaptive 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.

Sponsors & Collaborators

  • Galway University Hospitals

    collaborator UNKNOWN

  • National University of Ireland, Galway, Ireland

    lead OTHER

Principal Investigators

  • Michael J Kerin, MB BCh BAO MCh DSc · University of Galway

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2028-11-01
Completion
2029-08-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799337 on ClinicalTrials.gov