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CompletedNCT06207708Updated Feb 13, 2025

Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy

An observational study in Head and Neck Cancer, sponsored by CNAO National Center of Oncological Hadrontherapy. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by CNAO National Center of Oncological Hadrontherapy · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Head and Neck Cancer

Keywords

  • particle therapy
  • head neck cancer
  • sarcopenia
  • hadrontherapy
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 70 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

CNAO National Center of Oncological Hadrontherapy is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

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

06

What researchers measure

Primary outcomes

  1. skeletal muscle strength mass (SMM)

    measurement of sarcopenia to evaluate the development of the affection

    Time frame: before starting hadrontherapy treatment

07

Study locations

1 site
  • CNAO
    Pavia, Pv 27100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06207708
Lead sponsor
CNAO National Center of Oncological Hadrontherapy
Responsible party
Sponsor
First posted
Jan 17, 2024
Start date
Apr 18, 2023
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Feb 13, 2025

Study contacts

Rossana Ingargiola, MD
principal investigator · CNAO National Center of Oncological Hadrontherapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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