Impact of Low Muscle Mass in HNC Treated With Immunotherapy

Sarcopenia Clinical Trial

— IMMUNONUTRI  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721184
• Other study ID #: PR299/20
• Status: Recruiting
• Start date: January 20, 2021
• Est. completion date: August 2024

Study information

• Verified date: January 2021
• Source: Institut Català d'Oncologia
• Contact: Lorena Arribas
• Phone: 932607751
• Email: larribas[@]iconcologia.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Small Cell
• Head and Neck Small Cell Carcinoma
• Sarcopenia
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
Spain	Institut Catala d'Oncologia	L'Hospitalet De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut Català d'Oncologia	Department of Health, Generalitat de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline
Secondary	- 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	2-3 months and 6 months
Secondary	Evaluate baseline muscle mass as a predictive biomarker of toxicity	Assessed by CT scan at L3 level	2-3 months and 6 months
Secondary	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	6 months
Secondary	Evaluate changes in body composition	Assessed by CT scan at L3 level	2-3 months and 6 months
Secondary	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	through study completion, on average of 6 months
Secondary	Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes	Assessed by CT scan at L3 level and blood sample	2-3 months and 6 months