Head and Neck Small Cell Carcinoma, Sarcopenia
Conditions
Keywords
head and neck cancer, immune checkpoint inhibitors, muscle mass, sarcopenia
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.
Interventions
None listed
Sponsors
Department of Health, Generalitat de Catalunya
Institut Català d'Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | at baseline | Assessed by CT scan at L3 level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate baseline muscle mass as a predictive biomarker of toxicity | 2-3 months and 6 months | Assessed by CT scan at L3 level |
| Evaluate the impact of adipose tissue as a predictor of survival and toxicity | 6 months | Assessed by CT scan at L3 level including total adipose tissue, subcutaneous, visceral and intramuscular fat mass |
| - 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 | Evaluated by full nutritional assessment |
| Evaluate the need for nutritional support throughout the treatment and the type if so | through study completion, on average of 6 months | Evaluated after performed full nutritional assessment by a checklist with all different options |
| Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes | 2-3 months and 6 months | Assessed by CT scan at L3 level and blood sample |
| Evaluate changes in body composition | 2-3 months and 6 months | Assessed by CT scan at L3 level |
Countries
Spain
Contacts
Primary ContactLorena Arribas
Outcome results
None listed