Clinical trial · Observational
Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients
Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors
NCT07130981CI-TRIAL-00094059recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Psychosocial Functioning | — | UNRESOLVED | — |
| Treatment Side Effects | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Body composition evaluation
- timeFrame
- 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.
- description
- 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 (2)
- measure
- Cachexia and psychosocial factors evaluation
- timeFrame
- Throughout 6 months of follow-up.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.