Study on How Immunotherapy Affects Fitness, Quality of Life, and Treatment Results in Adults With Solid Tumors

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.

IMMUNO-FIT Observational Study