Impact of Low Muscle Mass in HNC Treated With Immunotherapy

Study Overview
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Brief Summary
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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)

Detailed Description
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Body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in cancer patients with different locations and treatments. However, there are currently no data on impact of body composition and the oncological outcomes in SCCHN patients treated with immune checkpoint inhibitors (ICI) due to recurrence or metastasic disease.

Official Title
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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)

Conditions
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Head and Neck Small Cell Carcinoma, Sarcopenia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Assessed by CT scan at L3 level | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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. | Evaluated by full nutritional assessment | 2-3 months and 6 months | 
| Evaluate baseline muscle mass as a predictive biomarker of toxicity | Assessed by CT scan at L3 level | 2-3 months and 6 months | 
| Evaluate the impact of adipose tissue as a predictor of survival and toxicity | Assessed by CT scan at L3 level including total adipose tissue, subcutaneous, visceral and intramuscular fat mass | 6 months | 
| Evaluate changes in body composition | Assessed by CT scan at L3 level | 2-3 months and 6 months | 
| Evaluate the need for nutritional support throughout the treatment and the type if so | Evaluated after performed full nutritional assessment by a checklist with all different options | through study completion, on average of 6 months | 
| Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes | Assessed by CT scan at L3 level and blood sample | 2-3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, immune checkpoint inhibitors, muscle mass, sarcopenia