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Recruiting NCT05817617

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

— Observational Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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

Primary outcome measures

  • Vitamin D variation [Time frame: 7 weeks]
Secondary outcome measures (5)
  • Baseline vitamin D level and radiotherapy toxicity [Time frame: 8 weeks]
  • Baseline vitamin D level and response [Time frame: 12 weeks]
  • Baseline vitamin D level and relapse free survival [Time frame: up to 2 years]
  • Baseline vitamin D level and survival [Time frame: up to 2 years]
  • Variation of vitamin D level [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 10 centers
  • Ospedale Mons AR Dimiccoli — Barletta
  • Centro di Riferimento Oncologico - Aviano — Aviano
  • Ospedale dell'Angelo — Mestre
  • Ospedali Riuniti — Ancona
  • AORN San Pio — Benevento
  • IEO — Milan
  • Ospedale Niguarda — Milan
  • Ospedale del Mare — Naples
  • … and 2 more centers

Identifiers

NCT: NCT05817617 · CRO 2021.013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗