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

Recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT05817617
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

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

Study Timeline

• Study Start: 2021-08-08
• Study First Submitted: 2023-03-24
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-18
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 953

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin D variation	7 weeks	Difference in vitamin D levels between baseline and during radiotherapy

Secondary Outcome Measures

Name	Time	Method
Baseline vitamin D level and survival	up to 2 years	Impact of baseline vitamin D levels on overall survival
Baseline vitamin D level and radiotherapy toxicity	8 weeks	Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss \>10%)
Baseline vitamin D level and response	12 weeks	Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate)
Baseline vitamin D level and relapse free survival	up to 2 years	Impact of baseline vitamin D levels on relapse free survival
Variation of vitamin D level	4 weeks	Difference and relation between vitamin D levels at baseline and after 4 weeks

Trial Locations

Locations (10)

IEO; 🇮🇹 Milan, Italy

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Pordenone, Italy

Ospedale Mons AR Dimiccoli; 🇮🇹 Barletta, BAT, Italy

Ospedale dell'Angelo; 🇮🇹 Mestre, Venezia, Italy

Ospedali Riuniti; 🇮🇹 Ancona, Italy

AORN San Pio; 🇮🇹 Benevento, Italy

Ospedale Niguarda; 🇮🇹 Milano, Italy

Ospedale del Mare; 🇮🇹 Napoli, Italy

Azienda Ospedaliero Universitaria di Pisa; 🇮🇹 Pisa, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy