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IMMUNO-FIT Observational Study

NCT07354971 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2026-04-28

No results posted yet for this study

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 up to 24 months. All cancer treatment will remain standard of care.

A small number of participants will be invited to take part in an optional research biopsy at week 12 to explore how physical fitness relates to changes in the tumour's immune environment.

The study will help researchers understand natural changes in fitness during immunotherapy, identify whether baseline fitness is associated with treatment tolerance or outcomes, and generate information needed to design future trials testing exercise-based interventions during immunotherapy.

Conditions

  • Neoplasms
  • Immunotherapy
  • Physical Fitness
  • Quality of Life
  • Drug-Related Side Effects and Adverse Reactions

Interventions

OTHER

Observational Study - No Study Intervention

This is an observational study with no study-assigned interventions. All participants receive standard-of-care immunotherapy as prescribed by their treating oncologist. Immunotherapy may include anti-PD-1, anti-PD-L1, anti-CTLA-4 agents, or approved combination regimens. All doses, schedules, treatment modifications, delays, and discontinuations follow routine clinical practice and manufacturer guidance. Treatment decisions are made independently of the study. The study observes and records treatment administration, effects on fitness and quality of life, adverse events, and clinical outcomes without influencing clinical care.

Sponsors & Collaborators

  • University of Southampton

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Kashuf Khan, MBBS, MRCS · University of Southampton

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07354971 on ClinicalTrials.gov