Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

NCT06207708 | Completed

• 1 other identifier: CNAO 56 2023
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

particle therapy; head neck cancer; sarcopenia; hadrontherapy

Outcome Measures

Primary Outcomes (1)

• skeletal muscle strength mass (SMM)

  measurement of sarcopenia to evaluate the development of the affection

  before starting hadrontherapy treatment

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

CNAO

Pavia, Pv, 27100, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Rossana Ingargiola, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 17, 2024
• Study Start: April 18, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)