The Immuno-FIT Trial
Research type
Research Study
Full title
A phase II window observational and feasibility randomised controlled trial of exercise prehabilitation in cancer patients receiving immunotherapy.
IRAS ID
356874
Contact name
Kashuf Khan
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Immunotherapy is a cancer treatment that helps the immune system recognise and attack cancer cells. Whilst it can improve survival for many patients with solid tumours, it is associated with various side effects that can affect patients' wellbeing and physical fitness. These effects may impact quality of life and the ability to continue treatment, with some patients needing to pause or stop their therapy.
The ImmunoFIT study investigates how immunotherapy affects physical fitness and whether exercise training can help patients maintain their strength and wellbeing during treatment. The research has two main goals: first, to measure changes in fitness during the first 12 weeks of immunotherapy and understand how baseline fitness levels relate to treatment side effects, long-term health outcomes, and quality of life; second, to test whether a structured exercise programme delivered alongside immunotherapy can preserve or improve fitness compared to standard care alone. The study also explores whether being fitter at diagnosis or participating in exercise training influences how the body's immune system responds to treatment and affects the tumour environment.
The study comprises two phases conducted at University Hospital Southampton NHS Foundation Trust. The observational phase follows 67 participants to understand how immunotherapy affects fitness. The feasibility trial randomly assigns participants to receive either standard care or a personalised exercise programme involving supervised cycling sessions three times weekly for nine weeks, with intensity tailored to individual fitness levels.
Adult patients with solid tumours starting immunotherapy treatment are eligible to participate. The study involves fitness tests, questionnaires about quality of life, blood samples, and for some participants, optional research biopsies. Each participant may be followed for up to two years.
This research is funded by The Royal Marsden Cancer Charity and the NIHR Biomedical Research Centre Southampton. The findings could inform personalised exercise strategies to improve cancer treatment outcomes and enhance patient wellbeing during immunotherapy.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0293
Date of REC Opinion
22 Oct 2025
REC opinion
Further Information Favourable Opinion