Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis
1 other identifier
observational
953
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2021
CompletedFirst Submitted
Initial submission to the registry
March 24, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedOctober 25, 2023
April 1, 2023
3 years
March 24, 2023
October 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Vitamin D variation
Difference in vitamin D levels between baseline and during radiotherapy
7 weeks
Secondary Outcomes (5)
Baseline vitamin D level and radiotherapy toxicity
8 weeks
Baseline vitamin D level and response
12 weeks
Baseline vitamin D level and relapse free survival
up to 2 years
Baseline vitamin D level and survival
up to 2 years
Variation of vitamin D level
4 weeks
Study Arms (1)
Head and Neck cancer patients
candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation
Eligibility Criteria
Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)
You may qualify if:
- 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
You may not qualify if:
- distant metastases
- patients with known disorders of calcium/vitamin D metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ospedale Mons AR Dimiccoli
Barletta, BAT, Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Pordenone, 33081, Italy
Ospedale dell'Angelo
Mestre, Venezia, 30174, Italy
Ospedali Riuniti
Ancona, Italy
AORN San Pio
Benevento, Italy
IEO
Milan, Italy
Ospedale Niguarda
Milan, Italy
Ospedale del Mare
Napoli, Italy
Azienda Ospedaliero Universitaria di Pisa
Pisa, Italy
Policlinico Umberto I
Roma, 00161, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Fanetti, MD
Centro di Riferimento Oncologico (CRO), IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2023
First Posted
April 18, 2023
Study Start
August 8, 2021
Primary Completion
August 1, 2024
Study Completion (Estimated)
August 1, 2026
Last Updated
October 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
No sharing