Impact of Low Muscle Mass in HNC Treated With Immunotherapy (IMMUNONUTRI)

Institut Català d'Oncologia

Status: Enrolling

Conditions: Head and Neck Small Cell Carcinoma; Sarcopenia

Study type: Observational

Funder types: Other

Identifiers

NCT04721184

PR299/20

Details and patient eligibility

About

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)

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.