IMMUNONUTRI: Impact of Low Muscle Mass in HNC Treated With Immunotherapy

Sponsor

Institut Català d'Oncologia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04721184

Collaborator

Department of Health, Generalitat de Catalunya (Other)

120

Enrollment

Location

42.3

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Small Cell Carcinoma Sarcopenia

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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Outcome Measures

Primary Outcome Measures

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

- 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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.