IMMUNO-FIT Observational Study
This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Immunotherapy can cause a range of side effects that impact daily functioning and may lead to treatment delays or early discontinuation. Physical fitness may influ
| Condition(s) | Neoplasms, Immunotherapy, Physical Fitness, Quality of Life, Drug-Related Side Effects and Adverse Reactions |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Immunotherapy can cause a range of side effects that impact daily functioning and may lead to treatment delays or early discontinuation. Physical fitness may influence how well patients cope with treatment, yet little is known about how fitness changes during immunotherapy or whether baseline fitness is linked to outcomes. Participants will complete fitness testing using cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before starting immunotherapy and again 12 weeks later. Blood samples will also be taken, and long-term outcomes including survival, disease progression, and quality of life will be followed for |
| Who can participate | 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-C |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital Southampton NHS Foundation Trust |
| Locations | Southampton, Hampshire, United Kingdom |
| Start date | 2026-03-26 |
| NCT ID | NCT07354971 |
| Official listing | https://clinicaltrials.gov/study/NCT07354971 |