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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Small Cell Carcinoma
- Sponsor
- Institut Català d'Oncologia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 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)
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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)
Time Frame: at baseline
Assessed by CT scan at L3 level
Secondary Outcomes
- Evaluate the impact of adipose tissue as a predictor of survival and toxicity(6 months)
- - 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.(2-3 months and 6 months)
- Evaluate baseline muscle mass as a predictive biomarker of toxicity(2-3 months and 6 months)
- Evaluate changes in body composition(2-3 months and 6 months)
- Evaluate the need for nutritional support throughout the treatment and the type if so(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(2-3 months and 6 months)