Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients

Recruiting

• Conditions: Cancer; Psychosocial Functioning; Treatment Side Effects; Cachexia

• Registration Number: NCT07130981
• Lead Sponsor: Hacettepe University

Brief Summary

Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-18
• Study First Posted: 2025-08-19
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-24
• Study Start: 2025-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body composition evaluation	Patient recruitment is planned to occur over a 6-month period. Each participant will be followed for a maximum duration of 6 months from the initiation of immunotherapy.	Body Composition Parameters Description: Muscle area, muscle index, muscle density, lean body mass, and combined indices derived from routine abdominal imaging at the L3 vertebral level.; Unit of measure: cm², cm²/m², Hounsfield units (HU), kilograms. Tool: Routine clinical imaging analysis.

Secondary Outcome Measures

Name	Time	Method
Cachexia and psychosocial factors evaluation	Throughout 6 months of follow-up.	Cachexia Risk Scores Description: Composite scores reflecting cachexia status, based on multidimensional clinical and biochemical indicators.; Unit of measure: Scoring system Tool: Validated cachexia scoring system. Psychosocial Factor Scores Description: Scores representing levels of depression, anxiety, stress, and distress, assessed through validated self-report questionnaires.; Unit of measure: Questionnaire scores (scale ranges such as 0-21 or 0-10). Tool: Validated patient-reported outcome measures.
Drug Related Problems	Throughout 6 months of follow-up.	Drug-Related Problems (DRPs) Description: Number and type of drug-related problems identified during treatment follow-up.; Unit of measure: Count (number of problems per patient). Tool: Pharmaceutical Care Network Europe (PCNE) classification system. Immune-Related Adverse Events (irAEs) Description: Incidence and severity of immune-related adverse events occurring during immunotherapy.; Unit of measure: Percentage of patients; severity graded 1-5. Tool: Common Terminology Criteria for Adverse Events (CTCAE v5.0).

Trial Locations

Locations (1)

Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy; 🇹🇷 Ankara, Altındağ, Turkey