Clinical trial NCT05817617: Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 953
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)

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

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

Primary outcomes:
measure: Vitamin D variation
timeFrame: 7 weeks
Secondary outcomes:
measure: Baseline vitamin D level and radiotherapy toxicity
timeFrame: 8 weeks
measure: Baseline vitamin D level and response
timeFrame: 12 weeks
measure: Baseline vitamin D level and relapse free survival
timeFrame: up to 2 years
measure: Baseline vitamin D level and survival
timeFrame: up to 2 years
measure: Variation of vitamin D level
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barletta
country: Italy
facility: Ospedale Mons AR Dimiccoli
state: BAT
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
state: Pordenone
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
state: Venezia
city: Ancona
country: Italy
facility: Ospedali Riuniti
city: Benevento
country: Italy
facility: AORN San Pio
city: Milano
country: Italy
facility: Ospedale Niguarda
city: Milan
country: Italy
facility: IEO
city: Napoli
country: Italy
facility: Ospedale del Mare
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria di Pisa
city: Roma
country: Italy
facility: Policlinico Umberto I
Study officials:
affiliation: Centro di Riferimento Oncologico (CRO), IRCCS
name: Giuseppe Fanetti, MD
role: PRINCIPAL_INVESTIGATOR
References: