Impact of Low Muscle Mass in HNC Treated With Immunotherapy

Institut Català d'Oncologia120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Head and Neck Small Cell Carcinoma Sarcopenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

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)

Assessed by CT scan at L3 level

Time frame: at baseline

Secondary Outcomes

- 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

Time frame: 2-3 months and 6 months

Evaluate baseline muscle mass as a predictive biomarker of toxicity

Assessed by CT scan at L3 level

Time frame: 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

Time frame: 6 months

Evaluate changes in body composition

Assessed by CT scan at L3 level

Time frame: 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

Time frame: 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

Central Contacts

Lorena Arribas

CONTACT

932607751 larribas@iconcologia.net

Data from ClinicalTrials.gov

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