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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06207708

Enrollment

Registered

2024-01-17

Start date

2023-04-18

Completion date

2025-01-31

Last updated

2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

particle therapy, head neck cancer, sarcopenia, hadrontherapy

Brief 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

Interventions

OTHERquestionnaires 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_TESTblood biomarkers

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
skeletal muscle strength mass (SMM)	before starting hadrontherapy treatment	measurement of sarcopenia to evaluate the development of the affection

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026