Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

CNAO National Center of Oncological Hadrontherapy

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Other: questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement; Diagnostic Test: blood biomarkers

Study type: Observational

Funder types: Other

Identifiers

NCT06207708

CNAO 56 2023

Details and patient eligibility

About

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

Full description

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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