Head and Neck Cancer
Conditions
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
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D variation | 7 weeks | Difference in vitamin D levels between baseline and during radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline vitamin D level and radiotherapy toxicity | 8 weeks | Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss \>10%) |
| Baseline vitamin D level and response | 12 weeks | Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate) |
| Baseline vitamin D level and relapse free survival | up to 2 years | Impact of baseline vitamin D levels on relapse free survival |
| Baseline vitamin D level and survival | up to 2 years | Impact of baseline vitamin D levels on overall survival |
| Variation of vitamin D level | 4 weeks | Difference and relation between vitamin D levels at baseline and after 4 weeks |
Countries
Italy
Contacts
Primary ContactGiuseppe Fanetti, MD
Outcome results
None listed