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NCT Number: NCT05817617

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

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

Recruiting

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Mons AR Dimiccoli, Barletta, BAT, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vitamin D variation

    Time frame: 7 weeks

    Difference in vitamin D levels between baseline and during radiotherapy

Secondary outcomes

  1. Baseline vitamin D level and radiotherapy toxicity

    Time frame: 8 weeks

    Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss >10%)

  2. Baseline vitamin D level and response

    Time frame: 12 weeks

    Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate)

  3. Baseline vitamin D level and relapse free survival

    Time frame: up to 2 years

    Impact of baseline vitamin D levels on relapse free survival

  4. Baseline vitamin D level and survival

    Time frame: up to 2 years

    Impact of baseline vitamin D levels on overall survival

  5. Variation of vitamin D level

    Time frame: 4 weeks

    Difference and relation between vitamin D levels at baseline and after 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Fanetti, MD

CONTACT

[email protected]

+390434659146

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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