Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHacettepe University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Did not provide written informed consent
Patients deemed unsuitable by the physician
Trial population
The study population will consist of adult patients initiating immune checkpoint inhibitor therapy (ipilimumab, nivolumab, pembrolizumab, atezolizumab, or avelumab) at the Medical Oncology Outpatient Clinic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov