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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

953 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-08

Study Completion Date

2026-08-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and Neck cancer patients

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Fanetti, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico (CRO), IRCCS

Locations

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Ospedale Mons AR Dimiccoli

Barletta, BAT, Italy

Site Status ACTIVE_NOT_RECRUITING

Centro di Riferimento Oncologico - Aviano

Aviano, Pordenone, Italy

Site Status RECRUITING

Ospedale dell'Angelo

Mestre, Venezia, Italy

Site Status RECRUITING