Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis

Study Overview
=================
Brief Summary
-----------------
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: variation of vitamin D levels in the study population at different time points relation between therapy side effects and vitamin D level relation between disease outcome and vitamin D level Participants will be followed as per clinical practice

Detailed Description
-----------------
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

Official Title
-----------------
Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis: Prospective Multicenter Study of Head-Neck Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO)

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven HNSCC (squamous cell carcinomas), all subsites non-metastatic locally advanced stages patients candidate for radical or adjuvant radiotherapy patients candidate for bilateral neck irradiation written informed consent Exclusion Criteria: distant metastases patients with known disorders of calcium/vitamin D metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Head and Neck cancer patients<br>candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D variation | Difference in vitamin D levels between baseline and during radiotherapy | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |