Impact of Vitamin D on Head and Neck Cancer Outcomes
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)
This study is looking to see if vitamin D levels affect how well people with head and neck cancer do during treatment and how they feel afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 953 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | radiation |
| Locations | 10 sites (Barletta, BAT and 9 other locations) |
| Trial ID | NCT05817617 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between vitamin D levels and outcomes in patients with head and neck cancer. It will track variations in vitamin D levels at different time points and assess how these levels correlate with therapy side effects and disease prognosis. Participants will be monitored according to standard clinical practices, allowing for a comprehensive understanding of vitamin D's role in treatment outcomes for head and neck squamous cell carcinoma patients undergoing radiation therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed non-metastatic locally advanced head and neck squamous cell carcinoma who are candidates for radical or adjuvant radiotherapy.
Not a fit: Patients with distant metastases or known disorders of calcium/vitamin D metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how vitamin D levels influence treatment toxicity and prognosis, potentially guiding therapeutic strategies.
How similar studies have performed: While there are limited studies correlating vitamin D levels with outcomes in head and neck cancer, previous small studies suggest a potential link, making this approach both relevant and exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barletta, BAT and 9 other locations
- Ospedale Mons AR Dimiccoli — Barletta, Bat, Italy (Active_not_recruiting)
- Centro di Riferimento Oncologico - Aviano — Aviano, Pordenone, Italy (Recruiting)
- Ospedale dell'Angelo — Mestre, Venezia, Italy (Recruiting)
- Ospedali Riuniti — Ancona, Italy (Not_yet_recruiting)
- AORN San Pio — Benevento, Italy (Not_yet_recruiting)
- Ieo — Milan, Italy (Not_yet_recruiting)
- Ospedale Niguarda — Milan, Italy (Not_yet_recruiting)
- Ospedale del Mare — Naples, Italy (Not_yet_recruiting)
- Azienda Ospedaliero Universitaria di Pisa — Pisa, Italy (Not_yet_recruiting)
- Policlinico Umberto I — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Fanetti, MD — Centro di Riferimento Oncologico (CRO), IRCCS
- Study coordinator: Giuseppe Fanetti, MD
- Email: giuseppe.fanetti@cro.it
- Phone: +390434659146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.