Actively Recruiting

Age: 18Years +
All Genders
ID07354971

The Immuno-FIT Observational Study Investigating Effects of Immunotherapy on Fitness, Quality of Life, and Outcomes in Advanced Cancer Patients

Led by University Hospital Southampton NHS Foundation Trust · Updated on 2026-04-28

67

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University Hospital Southampton NHS Foundation Trust

Lead Sponsor

U

University of Southampton

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Since immunotherapy can cause side effects that impact daily life and treatment continuation, this study aims to understand fitness changes during treatment and whether initial fitness levels relate to outcomes. It is a Phase II observational study enrolling adults starting standard immune checkpoint inhibitor therapy for various solid tumors. Participants will undergo fitness testing using cardiopulmonary exercise testing (CPET) and complete quality-of-life questionnaires before starting immunotherapy and again after 12 weeks. Blood samples will be collected at both times. Immunotherapy treatment is given as usual without study intervention. Some participants may be invited to have an optional tumor biopsy at 12 weeks to explore links between fitness and tumor immune environment. The study also follows participants for up to 24 months to track survival, disease progression, and quality of life. During the study, researchers will record treatment details, side effects, and any treatment delays or changes. Assessments include CPET, questionnaires on physical and psychological health, blood tests, and medical record reviews. Follow-up visits occur around 6, 12, and 24 months after treatment start to monitor long-term outcomes. Data will help understand fitness changes during immunotherapy, their relation to treatment tolerance and results, and guide future trials of exercise during immunotherapy.

CONDITIONS

Brief Title

IMMUNO-FIT Observational Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed solid malignancy
  • Receiving immune checkpoint inhibitors in adjuvant or metastatic/palliative settings
  • ECOG Performance Status between 0 and 2
  • Able to perform cardiopulmonary exercise testing
  • Able to provide written informed consent
  • Willing and able to comply with study procedures and follow-up schedule
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Prior systemic immunotherapy for unresectable or metastatic disease, except stabilized prior adjuvant or neoadjuvant immunotherapy
  • Prior checkpoint inhibitor therapy with less than 6 months since last dose and disease recurrence
  • Absolute contraindications to cardiopulmonary exercise testing such as recent heart attack, unstable angina, uncontrolled arrhythmias, active endocarditis, severe aortic stenosis, uncontrolled heart failure, recent pulmonary embolism, myocarditis, pericarditis, suspected aneurysm, or systemic infection
  • Inability to perform exercise testing due to severe lower limb dysfunction or vascular disease
  • Unable to provide informed consent
  • Currently enrolled in another interventional clinical trial that could affect outcomes
  • For biopsy sub-study: severe cardiopulmonary disease, suspected bowel obstruction or perforation, severe coagulopathy, severe portal hypertension with high-risk varices, or inaccessible biopsy lesion as determined by clinician

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Baseline Assessment

Duration - Approximately 2 weeks before immunotherapy

Participants undergo baseline assessments including cardiopulmonary exercise testing (CPET), quality-of-life questionnaires, blood sampling, and review of medical history before starting immunotherapy.

1 baseline visit (in-person)

Monitoring During Immunotherapy

Duration - First 12 weeks of immunotherapy

Participants receive standard-of-care immunotherapy and are monitored for treatment regimens, immune-related and treatment-related adverse events, treatment delays, dose modifications, discontinuations, and healthcare utilization.

Visits as per routine clinical practice

Follow-up Assessment at 12 Weeks

Duration - At approximately 12 weeks after starting immunotherapy

Participants repeat baseline assessments including CPET, quality-of-life and psychosocial questionnaires, blood sampling, and imaging to evaluate response and treatment status.

1 follow-up visit (in-person)

Long-term Monitoring

Duration - Up to 24 months after treatment initiation

Participants are followed up at 6, 12, and 24 months from treatment start to assess survival status, disease progression, ongoing treatment and toxicity, healthcare utilization, and repeated quality-of-life assessments.

3 follow-up contacts (may be electronic, telephone, or paper-based)

Trial Site Locations

Total: 1 location

1

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

K

Kashuf Khan, MBBS, MRCS

M

Malcolm West, MD, PhD, FEBS, FRCS,

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Cardiopulmonary exercise testing has greater prognostic value than sarcopenia in oesophago-gastric cancer patients undergoing neoadjuvant therapy and surgical resection.

Malcolm A West, William Ca Baker, Saqib Rahman...

https://pubmed.ncbi.nlm.nih.gov/34463378

The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial).

Lisa Loughney, Malcolm A West, Helen Moyses...

https://pubmed.ncbi.nlm.nih.gov/34154675