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

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement; Diagnostic test: blood biomarkers

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

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Italy
  • Pv
    • Pavia, Pv, Italy, 27100
      • CNAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A sample of 70 patients of which 40% showing baseline sarcopenia will be recruited. The population is composed by head and neck patients treated with particle therapy, both carbon ions and protons.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CNAO National Center of Oncological Hadrontherapy
• Investigators: Principal Investigator: Rossana Ingargiola, MD, CNAO National Center of Oncological Hadrontherapy

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: sarcopenia; head neck cancer; particle therapy; hadrontherapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Head and Neck Neoplasms; Sarcopenia
• Other Study ID Numbers: CNAO 56 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No