Trial Title:
Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis
NCT ID:
NCT05817617
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
Criteria for eligibility:
Study pop:
Patients of the participant centers with histologically proven HNSCC (squamous cell
carcinomas)
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedale Mons AR Dimiccoli
Address:
City:
Barletta
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Centro di Riferimento Oncologico - Aviano
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Fanetti, MD
Phone:
0434 659146
Email:
giuseppe.fanetti@cro.it
Contact backup:
Last name:
Martina Zanchetta, PhD
Phone:
0434 659078
Email:
martina.zanchetta@cro.it
Facility:
Name:
Ospedale dell'Angelo
Address:
City:
Mestre
Zip:
30174
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Melissa Scricciolo
Facility:
Name:
Ospedali Riuniti
Address:
City:
Ancona
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Clelia Di Carlo
Facility:
Name:
AORN San Pio
Address:
City:
Benevento
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Angela Argenone
Facility:
Name:
Ospedale Niguarda
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Daniela Sibio
Facility:
Name:
IEO
Address:
City:
Milan
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Daniela Alterio
Facility:
Name:
Ospedale del Mare
Address:
City:
Napoli
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ida D'Onofrio
Facility:
Name:
Azienda Ospedaliero Universitaria di Pisa
Address:
City:
Pisa
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Stefano Ursino
Facility:
Name:
Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesca De Felice
Start date:
August 8, 2021
Completion date:
August 2026
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05817617
