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The goal of this observational study is to learn about relation between vitamin D levels in subjects with head and neck cancer. The main question it aims to answer are:
There are only a few works in the literature that correlate the circulating levels of vitamin D with the prognosis or development of toxicity in treated HNSCC patients with radical intent radiation therapy. These small studies have highlighted a worse outcome and greater toxicity in patients with low vitamin D levels. The study aims to study the variations in circulating levels of vitamin D in a multicenter cohort of patients with HSNCC prospectively collected and to evaluate the impact of vitamin D levels at diagnosis on the development of toxicity and on disease outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and Neck cancer patients | candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation |
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| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D variation | Difference in vitamin D levels between baseline and during radiotherapy | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline vitamin D level and radiotherapy toxicity | Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss >10%) | 8 weeks |
| Baseline vitamin D level and response |
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Inclusion Criteria:
histologically proven HNSCC (squamous cell carcinomas), all subsites
Exclusion Criteria:
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Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Fanetti, MD | Contact | +390434659146 | giuseppe.fanetti@cro.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Fanetti, MD | Centro di Riferimento Oncologico (CRO), IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Mons AR Dimiccoli | Active, not recruiting | Barletta | BAT | Italy | ||
| Centro di Riferimento Oncologico - Aviano |
No sharing
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate)
| 12 weeks |
| Baseline vitamin D level and relapse free survival | Impact of baseline vitamin D levels on relapse free survival | up to 2 years |
| Baseline vitamin D level and survival | Impact of baseline vitamin D levels on overall survival | up to 2 years |
| Variation of vitamin D level | Difference and relation between vitamin D levels at baseline and after 4 weeks | 4 weeks |
| Recruiting |
| Aviano |
| Pordenone |
| 33081 |
| Italy |
|
| Ospedale dell'Angelo | Recruiting | Mestre | Venezia | 30174 | Italy |
|
| Ospedali Riuniti | Not yet recruiting | Ancona | Italy |
|
| AORN San Pio | Not yet recruiting | Benevento | Italy |
|
| IEO | Not yet recruiting | Milan | Italy |
|
| Ospedale Niguarda | Not yet recruiting | Milan | Italy |
|
| Ospedale del Mare | Not yet recruiting | Naples | Italy |
|
| Azienda Ospedaliero Universitaria di Pisa | Not yet recruiting | Pisa | Italy |
|
| Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
|