Impact of Low Muscle Mass in HNC Treated With Immunotherapy

• Conditions: Sarcopenia; Head and Neck Small Cell Carcinoma

• Registration Number: NCT04721184
• Lead Sponsor: Institut Català d'Oncologia

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.

Study Timeline

• Study First Submitted: 2020-11-25
• Status Verified: 2021-01
• Study Start: 2021-01-20
• Study First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Primary Completion: 2023-11
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 baseline muscle mass as a predictive biomarker of toxicity	2-3 months and 6 months	Assessed by CT scan at L3 level
Evaluate changes in body composition	2-3 months and 6 months	Assessed by CT scan at L3 level
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

Trial Locations

Locations (1)

Institut Catala d'Oncologia; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain