NCT06207708

Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated with Curative Hadrontherapy: a Prospective Monoinstitutional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: CNAO National Center of Oncological Hadrontherapy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement	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
DIAGNOSTIC_TEST	blood biomarkers	as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected

Timeline

• Start date: 2023-04-18
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-01-17
• Last updated: 2025-02-13

Locations

1 site across 1 country: Italy