IMMUNO-FIT: How immunotherapy affects fitness and quality of life in adults with solid cancers
The Immuno-FIT Observational Study: A Phase II Window Observational Study Investigating the Effects of Immunotherapy on Cardiopulmonary Fitness, Quality of Life, and Treatment Outcomes in Patients With Advanced Cancer
We will see if starting immunotherapy changes physical fitness, quality of life, and how well adults with solid cancers tolerate treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Southampton, Hampshire) |
| Trial ID | NCT07354971 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with solid tumors who are starting immune checkpoint inhibitors to see how treatment affects cardiorespiratory fitness, quality of life, and treatment tolerance. Participants complete cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before immunotherapy and again at 12 weeks; blood samples are collected and a small subset may be invited for an optional research biopsy at week 12. Clinical outcomes including survival, disease progression, treatment interruptions, and ongoing quality-of-life measures are tracked for up to 24 months while patients receive standard-of-care treatment. No experimental therapies are given; the study links objective fitness measures and biomarkers to treatment side effects and longer-term outcomes.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed solid cancers who are starting single-agent or dual-agent immune checkpoint inhibitors, have ECOG performance status 0–2, and can safely undergo CPET are the intended participants.
Not a fit: Patients unable to perform CPET, those with poor performance status, or those with prior systemic immunotherapy for unresectable/metastatic disease outside the allowed exceptions may not benefit from or be eligible for this study.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk of treatment toxicity or early discontinuation and guide use of fitness-based supportive care to improve outcomes.
How similar studies have performed: Previous studies have shown chemotherapy can reduce CPET-measured fitness and that exercise prehabilitation can help, but the specific impact of immune checkpoint inhibitors on objective fitness and related outcomes is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Histologically confirmed solid malignancy * Receiving immune checkpoint inhibitors in one of the following settings: * Adjuvant: Single-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4 * Metastatic/Palliative: Single-agent or dual-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4 * ECOG Performance Status 0-2 * Able to perform cardiopulmonary exercise testing * Able to provide written informed consent * Willing and able to comply with study procedures and follow-up schedule Exclusion Criteria: * Age \<18 years * Prior systemic anti-cancer immunotherapy for unresectable or metastatic disease, EXCEPT: * Prior adjuvant or neoadjuvant immunotherapy if all treatment-related adverse events have returned to baseline or stabilized * Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy with at least 6 months since last dose and date of disease recurrence * Absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction within 6 weeks * Unstable angina * Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise * Active endocarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolism or pulmonary infarction * Acute myocarditis or pericarditis * Suspected or known dissecting aneurysm * Acute systemic infection * Inability to perform cardiopulmonary exercise testing (e.g., severe lower limb dysfunction, severe peripheral vascular disease) * Inability to provide informed consent * Currently enrolled in another interventional clinical trial that would confound study outcomes ADDITIONAL EXCLUSION CRITERIA FOR RESEARCH BIOPSY SUB-STUDY: * Severe cardiopulmonary disease precluding safe sedation (for endoscopic biopsies) * Suspected bowel obstruction or perforation (for gastrointestinal biopsies) * Uncorrectable severe coagulopathy (INR \>1.5, platelet count \<50,000/µL) * Severe portal hypertension with high-risk varices (for upper endoscopy) * Lesion inaccessible for safe biopsy as determined by a performing clinician
Where this trial is running
Southampton, Hampshire
- University Hospital Southampton NHS Foundation Trust — Southampton, Hampshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kashuf Khan, MBBS, MRCS — University of Southampton
- Study coordinator: Kashuf Khan, MBBS, MRCS
- Email: k.a.khan@soton.ac.uk
- Phone: +442381204308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.