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
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
Study Type
OBSERVATIONAL
Enrollment
953
Ospedale Mons AR Dimiccoli
Barletta, BAT, Italy
ACTIVE_NOT_RECRUITINGCentro di Riferimento Oncologico - Aviano
Aviano, Pordenone, Italy
RECRUITINGOspedale dell'Angelo
Mestre, Venezia, Italy
Vitamin D variation
Difference in vitamin D levels between baseline and during radiotherapy
Time frame: 7 weeks
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%)
Time frame: 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)
Time frame: 12 weeks
Baseline vitamin D level and relapse free survival
Impact of baseline vitamin D levels on relapse free survival
Time frame: up to 2 years
Baseline vitamin D level and survival
Impact of baseline vitamin D levels on overall survival
Time frame: up to 2 years
Variation of vitamin D level
Difference and relation between vitamin D levels at baseline and after 4 weeks
Time frame: 4 weeks
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Ospedali Riuniti
Ancona, Italy
NOT_YET_RECRUITINGAORN San Pio
Benevento, Italy
NOT_YET_RECRUITINGIEO
Milan, Italy
NOT_YET_RECRUITINGOspedale Niguarda
Milan, Italy
NOT_YET_RECRUITINGOspedale del Mare
Napoli, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero Universitaria di Pisa
Pisa, Italy
NOT_YET_RECRUITINGPoliclinico Umberto I
Roma, Italy
RECRUITING