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

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817617
• Other study ID #: CRO 2021.013
• Status: Recruiting
• Start date: August 8, 2021
• Est. completion date: August 2026

Study information

• Verified date: April 2023
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Giuseppe Fanetti, MD
• Phone: +390434659146
• Email: giuseppe.fanetti[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 953
• Est. completion date: August 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Ancona
Italy	Centro di Riferimento Oncologico - Aviano	Aviano	Pordenone
Italy	Ospedale Mons AR Dimiccoli	Barletta	BAT
Italy	AORN San Pio	Benevento
Italy	Ospedale dell'Angelo	Mestre	Venezia
Italy	IEO	Milan
Italy	Ospedale Niguarda	Milano
Italy	Ospedale del Mare	Napoli
Italy	Azienda Ospedaliero Universitaria di Pisa	Pisa
Italy	Policlinico Umberto I	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D variation	Difference in vitamin D levels between baseline and during radiotherapy	7 weeks
Secondary	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
Secondary	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
Secondary	Baseline vitamin D level and relapse free survival	Impact of baseline vitamin D levels on relapse free survival	up to 2 years
Secondary	Baseline vitamin D level and survival	Impact of baseline vitamin D levels on overall survival	up to 2 years
Secondary	Variation of vitamin D level	Difference and relation between vitamin D levels at baseline and after 4 weeks	4 weeks