Head and Neck CancerNCT05817617
Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis
An observational study of Head and Neck Cancer, run by Centro di Riferimento Oncologico - Aviano at 10 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 953 participants
- Where
- 10 sitesItaly
- Study dates
- 8 Aug 2021to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)
Who may be able to join
- 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
Who cannot join
- distant metastases
- patients with known disorders of calcium/vitamin D metabolism
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites, 9 recruiting
- Not yet recruiting
Ospedali Riuniti
Ancona
Clelia Di Carlo
- Recruiting
Centro di Riferimento Oncologico - Aviano
Aviano, Pordenone, 33081
Giuseppe Fanetti, MD, 0434 659146, giuseppe.fanetti@cro.it
Martina Zanchetta, PhD, 0434 659078, martina.zanchetta@cro.it
- Active, not recruiting
Ospedale Mons AR Dimiccoli
Barletta, BAT
- Not yet recruiting
AORN San Pio
Benevento
Angela Argenone
- Recruiting
Ospedale dell'Angelo
Mestre, Venezia, 30174
Melissa Scricciolo
- Not yet recruiting
IEO
Milan
Daniela Alterio
- Not yet recruiting
Ospedale Niguarda
Milan
Daniela Sibio
- Not yet recruiting
Ospedale del Mare
Naples
Ida D'Onofrio
- Not yet recruiting
Azienda Ospedaliero Universitaria di Pisa
Pisa
Stefano Ursino
- Recruiting
Policlinico Umberto I
Roma, 00161
Francesca De Felice
About this study
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)
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
Read the 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
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck cancer patients | candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D variation
Difference in vitamin D levels between baseline and during radiotherapy
Measured: 7 weeks
Secondary outcomes (5)
Baseline vitamin D level and radiotherapy toxicity
Evaluation of the impact of baseline vitamin D levels on acute toxicity (mucositis, dermatitis and weight loss >10%)
Measured: 8 weeks
Baseline vitamin D level and response
Evaluation of the impact of baseline vitamin D levels on response measured in term of ORR (Objective Response Rate)
Measured: 12 weeks
Baseline vitamin D level and relapse free survival
Impact of baseline vitamin D levels on relapse free survival
Measured: up to 2 years
Baseline vitamin D level and survival
Impact of baseline vitamin D levels on overall survival
Measured: up to 2 years
Variation of vitamin D level
Difference and relation between vitamin D levels at baseline and after 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start8 Aug 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 953 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Fanetti, MD, Principal investigator, Centro di Riferimento Oncologico (CRO), IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817617
- Sponsor's protocol ID
- CRO 2021.013
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05817617
- Acronym / sponsor ID
- CRO 2021.013
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 953 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck cancer patients | – | –candidate to receive definitive or adjuvant radiation therapy with bilateral neck irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the participant centers with histologically proven HNSCC (squamous cell carcinomas)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- distant metastases
- patients with known disorders of calcium/vitamin D metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D variation
Time frame: 7 weeks
Difference in vitamin D levels between baseline and during radiotherapy
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No. No sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Fanetti, MD principal investigator
Centro di Riferimento Oncologico (CRO), IRCCS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Centro di Riferimento Oncologico - Aviano at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Fanetti, MD (+390434659146, giuseppe.fanetti@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D variation (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.