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Study on Vitamin D Levels in Adults with Head and Neck Cancer Receiving Radiation Therapy and Their Impact on Treatment Side Effects and Outcomes
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2023-10-25
953
Participants Needed
10
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
This observational study focuses on patients with head and neck squamous cell carcinoma HNSCC undergoing radical or adjuvant radiation therapy. Researchers aim to understand how vitamin D levels vary over time in these patients and how these levels relate to therapy side effects, disease outcomes, and toxicity. The study addresses gaps in current knowledge by prospectively evaluating vitamin Ds potential impact on treatment results and patient prognosis across multiple centers. Participants will be patients with confirmed non-metastatic locally advanced HNSCC who are candidates for bilateral neck irradiation as part of their radiation therapy. The study does not involve experimental treatments but follows patients as per standard clinical practice. Vitamin D levels will be measured at diagnosis and at various time points, including 4 and 7 weeks, to observe variations and possible links with treatment toxicity and disease response. During the study, researchers will collect data on vitamin D levels alongside monitoring radiotherapy side effects, treatment responses, relapse-free survival, and overall survival up to two years. Follow-up aligns with routine clinical care, and no additional interventions are given. The primary outcome is vitamin D variation at 7 weeks, with secondary outcomes including toxicity, response, and survival measures. Participants involvement mainly consists of blood tests and clinical evaluations conducted during their regular treatment visits.
CONDITIONS
Brief Title
Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis
Research Team
G
Giuseppe Fanetti, MD
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