Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis

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)

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer

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

• Study Type: Observational
• Enrollment (Estimated): 953

Contacts and Locations

• Study Contact: Name: Giuseppe Fanetti, MD; Phone Number: +390434659146; Email: giuseppe.fanetti@cro.it

Study Locations

• Italy
  • Ancona, Italy
    • Not yet recruiting
    • Ospedali Riuniti
    • Contact: Clelia Di Carlo
  • Benevento, Italy
    • Not yet recruiting
    • Aorn San Pio
    • Contact: Angela Argenone
  • Milan, Italy
    • Not yet recruiting
    • IEO
    • Contact: Daniela Alterio
  • Milano, Italy
    • Not yet recruiting
    • Ospedale Niguarda
    • Contact: Daniela Sibio
  • Napoli, Italy
    • Not yet recruiting
    • Ospedale del Mare
    • Contact: Ida D'Onofrio
  • Pisa, Italy
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria di Pisa
    • Contact: Stefano Ursino
  • Roma, Italy, 00161
    • Recruiting
    • Policlinico Umberto I
    • Contact: Francesca De Felice
  • BAT
    • Barletta, BAT, Italy
      • Active, not recruiting
      • Ospedale Mons AR Dimiccoli
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico - Aviano
      • Contact: Giuseppe Fanetti, MD; Phone Number: 0434 659146; Email: giuseppe.fanetti@cro.it
      • Contact: Martina Zanchetta, PhD; Phone Number: 0434 659078; Email: martina.zanchetta@cro.it
  • Venezia
    • Mestre, Venezia, Italy, 30174
      • Recruiting
      • Ospedale dell'Angelo
      • Contact: Melissa Scricciolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Head and Neck cancer patients; candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D variation	Difference in vitamin D levels between baseline and during radiotherapy	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%)	8 weeks
Variation of vitamin D level	Difference and relation between vitamin D levels at baseline and after 4 weeks	4 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)	12 weeks
Baseline vitamin D level and relapse free survival	Impact of baseline vitamin D levels on relapse free survival	up to 2 years
Baseline vitamin D level and survival	Impact of baseline vitamin D levels on overall survival	up to 2 years

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Giuseppe Fanetti, MD, Centro di Riferimento Oncologico (CRO), IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CRO 2021.013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing