NCT04721184

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Head and Neck Small Cell Carcinoma
• Sarcopenia

Timeline

• Start date: 2021-01-20
• Primary completion: 2023-11-01
• Completion: 2024-08-01
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: Spain