Impact of Low Muscle Mass in HNC Treated With Immunotherapy

NCT04721184 | Unknown

• 1 other identifier: PR299/20
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Conditions

Head and Neck Small Cell Carcinoma; Sarcopenia

Keywords

head and neck cancer; immune checkpoint inhibitors; muscle mass; sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• - 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

• Evaluate baseline muscle mass as a predictive biomarker of toxicity

  2-3 months and 6 months

• Evaluate the impact of adipose tissue as a predictor of survival and toxicity

  6 months

• Evaluate changes in body composition

  2-3 months and 6 months

• Evaluate the need for nutritional support throughout the treatment and the type if so

  through study completion, on average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (1)

Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Lorena Arribas

  Institut Catlà d'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorena Arribas

CONTACT

932607751; larribas@iconcologia.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: January 22, 2021
• Study Start: January 20, 2021
• Primary Completion: November 1, 2023
• Study Completion: August 1, 2024
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

ES (1)