How body composition and psychosocial health relate to outcomes for people receiving immune checkpoint inhibitors
Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors
This project will see if body composition, psychosocial health, and medication-related problems affect side effects, treatment response, and quality of life in adults with cancer treated with immune checkpoint inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara, Altındağ) |
| Trial ID | NCT07130981 on ClinicalTrials.gov |
What this trial studies
This observational project will use pre-treatment CT scans at the L3 level to measure body composition and collect questionnaires on psychosocial factors and drug-related problems in adults starting immune checkpoint inhibitors. Clinical outcomes such as treatment toxicity, tumor response, and patient-reported quality of life will be followed through medical records and patient reports. No experimental treatment is given; researchers will analyze associations between body composition, psychosocial and medication issues, and clinical progression. Enrollment and follow-up visits take place at Hacettepe University Faculty of Pharmacy in Ankara.
Who should consider this trial
Good fit: Adults (18+) with cancer who have a pre-treatment CT scan at the L3 level, can communicate effectively, provided written informed consent, and are being treated with immune checkpoint inhibitors are ideal candidates.
Not a fit: People not receiving immune checkpoint inhibitors, those without a qualifying pre-treatment L3 CT scan, or those unable to consent or communicate are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk of toxicity or poor response and guide more personalized monitoring and supportive care.
How similar studies have performed: Previous research has linked sarcopenia and psychosocial factors to cancer outcomes and some ICI toxicities, but combining body composition with psychosocial and medication-related problems in ICI patients is a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Having undergone a CT scan (at the L3 level) prior to treatment * No severe mental disorder and able to communicate effectively * Provided written informed consent Exclusion Criteria: * Did not provide written informed consent * Patients deemed unsuitable by the physician
Where this trial is running
Ankara, Altındağ
- Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy — Ankara, Altındağ, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: İzgi BAYRAKTAR, PhD (c)- Lecturer
- Email: izgibayraktar@gmail.com
- Phone: +905342996472
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.