Skip to main content
OpenTrials
Completed

NCT Number: NCT06207708

Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Atrophy Head and Neck Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CNAO

Pavia, Pv, 27100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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 Biomarkers

Diagnostic Test

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

Primary outcomes

  1. skeletal muscle strength mass (SMM)

    Time frame: before starting hadrontherapy treatment

    measurement of sarcopenia to evaluate the development of the affection

Sponsors and collaborators

Lead sponsor

CNAO National Center of Oncological Hadrontherapy

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.