Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07130981

Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Body Weight Body Weight Changes Cachexia Neoplasms Pathological Conditions, Signs and Symptoms Psychosocial Functioning Signs and Symptoms Thinness Treatment Side Effects Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Aygin Ekincioglu, Professor

CONTACT

[email protected]

(0 312) 305 20 43

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Body composition evaluation

    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.

    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 outcomes

  1. Cachexia and psychosocial factors evaluation

    Time frame: 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.

  2. Drug Related Problems

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aygin Ekincioglu, Prof.Dr. -Head of department

CONTACT

[email protected]

+90 532 355 07 46

İzgi BAYRAKTAR, PhD (c)- Lecturer

CONTACT

[email protected]

+905342996472

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.