Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

N/ACompletedNCT06207708

CNAO National Center of Oncological Hadrontherapy70 enrolled

Overview

The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.

To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as: * Acute toxicity: within 3 months from the beginning of particle RT * Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer

Interventions

questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurementOTHER

the patient is administered with questionnaires focused on diet, fatigue, nutrition screening and on body mass index at the beginning and at the end pf particle therapy radiation treatment

blood biomarkersDIAGNOSTIC_TEST

as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All HNC histologies and stages * Histological and/or radiological diagnosis of head and neck tumors * The patient is able to give consent * Definitive/postoperative treatment with curative intent * Age \>18 years * KPS\> 80 Exclusion Criteria: * Plurimetastiatic disease * Palliative intent and re-irradiation treatments * Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires

Locations (1)

CNAO

Pavia, Pv, Italy

Outcomes

Primary Outcomes

skeletal muscle strength mass (SMM)

measurement of sarcopenia to evaluate the development of the affection

Time frame: before starting hadrontherapy treatment

Data from ClinicalTrials.gov

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