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

Centro di Riferimento Oncologico - Aviano

Status: Enrolling

Conditions: Head and Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05817617

CRO 2021.013

Details and patient eligibility

About

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

Full 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

Enrollment: 953 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

953 participants in 1 patient group

Head and Neck cancer patients

Description:

candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation