Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients

Hacettepe University200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Cancer Psychosocial Functioning Treatment Side Effects Cachexia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy

Ankara, Altındağ, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Body composition evaluation

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.

Time frame: 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.

Secondary Outcomes

Cachexia and psychosocial factors evaluation

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.

Time frame: Throughout 6 months of follow-up.

Drug Related Problems

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).

Time frame: Throughout 6 months of follow-up.

Central Contacts

İzgi BAYRAKTAR, PhD (c)- Lecturer

CONTACT

+905342996472 izgibayraktar@gmail.com

Aygin Ekincioglu, Prof.Dr. -Head of department

CONTACT

+90 532 355 07 46 aygin@hacettepe.edu.tr

Data from ClinicalTrials.gov

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