Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy
Completed
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT06207708
- Lead Sponsor
- CNAO National Center of Oncological 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method skeletal muscle strength mass (SMM) before starting hadrontherapy treatment measurement of sarcopenia to evaluate the development of the affection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CNAO
🇮🇹Pavia, Pv, Italy