Clinical trial · Observational
Impact of Low Muscle Mass in HNC Treated With Immunotherapy
Impact of Body Composition on the Prognosis and Toxicity of Patients Diagnosed With Recurrence or Metastasic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treated With Immune Checkpoint Inhibitors (ICI)
NCT04721184CI-TRIAL-00049552IMMUNONUTRIunknownClinicalTrials.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)
The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Small Cell Carcinoma | Head and Neck Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
- timeFrame
- at baseline
- description
- Assessed by CT scan at L3 level
Secondary outcomes (6)
- measure
- - To evaluate the impact of malnutrition and weight loss on overall survival, recurrence-free survival, locoregional control, and toxicity in patients with recurrence or metastatic SCCHN treated with immunotherapy-based regimens.
- timeFrame
- 2-3 months and 6 months
- description
- Evaluated by full nutritional assessment
- measure
- Evaluate baseline muscle mass as a predictive biomarker of toxicity
- timeFrame
- 2-3 months and 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with recurrence or metastatic SCCHN treated with antiPDL1, antiPD1 or antiCTLA-4 drugs, alone or in combination within our institution. * Patients who have previously signed informed consent. * Patients with measurable tumor lesions. Exclusion Criteria: * Patients with non-measurable lesions. * Patients who do not sign the informed consent. * Patients not treated with immunotherapy. * Patients in a double-blind trial in whom the assigned branch is not known.
References
Publications (0)
Data not yet available
No reference posted for this study.