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| Name | Class |
|---|---|
| Department of Health, Generalitat de Catalunya | OTHER_GOV |
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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)
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A longitudinal prospective study will be carried out of 120 patients with a diagnosis of recurrence or metastatic SCCHN who start treatment with immunotherapy-based regimens at the Institut CatalĂ d'Oncologia- L'Hospitalet from November 2020 until the necessary sample size is completed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorena Arribas | Contact | 932607751 | larribas@iconcologia.net |
| Name | Affiliation | Role |
|---|---|---|
| Lorena Arribas | Institut CatlĂ d'Oncologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Catala d'Oncologia | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |