Clinical trial NCT04721184: Impact of Low Muscle Mass in HNC Treated With Immunotherapy
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Small Cell Carcinoma
Sarcopenia
Keywords: head and neck cancer
immune checkpoint inhibitors
muscle mass
sarcopenia
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
First posted: 2021-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: at baseline
Secondary outcomes:
measure: - 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.
timeFrame: 2-3 months and 6 months
measure: Evaluate baseline muscle mass as a predictive biomarker of toxicity
timeFrame: 2-3 months and 6 months
measure: Evaluate the impact of adipose tissue as a predictor of survival and toxicity
timeFrame: 6 months
measure: Evaluate changes in body composition
timeFrame: 2-3 months and 6 months
measure: Evaluate the need for nutritional support throughout the treatment and the type if so
timeFrame: through study completion, on average of 6 months
measure: Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes
timeFrame: 2-3 months and 6 months
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
Study officials:
affiliation: Institut Catlà d'Oncologia
name: Lorena Arribas
role: PRINCIPAL_INVESTIGATOR
References: