Impact of Low Muscle Mass in HNC Treated With Immunotherapy (IMMUNONUTRI)

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)

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)

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Head and Neck Small Cell Carcinoma

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Lorena Arribas; Phone Number: 932607751; Email: larribas@iconcologia.net

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Institut Catala d'Oncologia
      • Contact: Lorena Arribas; Phone Number: 932607751; Email: larribas@iconcologia.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A longitudinal prospective study will be carried out of 120 patients with a diagnosis of recurrence or metastatic SCCHN who start treatment with immunotherapy-based regimens at the Institut Català d'Oncologia- L'Hospitalet from November 2020 until the necessary sample size is completed.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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
Evaluate baseline muscle mass as a predictive biomarker of toxicity	Assessed by CT scan at L3 level	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	6 months
Evaluate changes in body composition	Assessed by CT scan at L3 level	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	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	Assessed by CT scan at L3 level and blood sample	2-3 months and 6 months

Collaborators and Investigators

• Sponsor: Institut Català d'Oncologia
• Collaborators: Department of Health, Generalitat de Catalunya
• Investigators: Principal Investigator: Lorena Arribas, Institut Catlà d'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: muscle mass; sarcopenia; head and neck cancer; immune checkpoint inhibitors
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Lung Neoplasms; Muscular Atrophy; Atrophy; Carcinoma; Sarcopenia; Small Cell Lung Carcinoma; Carcinoma, Small Cell
• Other Study ID Numbers: PR299/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No