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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06207708
Other study ID # CNAO 56 2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2023
Est. completion date November 18, 2024

Study information

Verified date January 2024
Source CNAO National Center of Oncological Hadrontherapy
Contact Rossana Ingargiola, MD
Phone 0382078501
Email rossana.ingargiola@cnao.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date November 18, 2024
Est. primary completion date November 18, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaires 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 Test:
blood biomarkers
as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected

Locations

Country Name City State
Italy CNAO Pavia Pv

Sponsors (1)

Lead Sponsor Collaborator
CNAO National Center of Oncological Hadrontherapy

Country where clinical trial is conducted

Italy, 

Outcome

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