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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 953
- 试验地点
- 10
- 主要终点
- Vitamin D variation
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •distant metastases
- •patients with known disorders of calcium/vitamin D metabolism
结局指标
主要结局
Vitamin D variation
时间窗: 7 weeks
Difference in vitamin D levels between baseline and during radiotherapy
次要结局
- Baseline vitamin D level and survival(up to 2 years)
- Baseline vitamin D level and radiotherapy toxicity(8 weeks)
- Baseline vitamin D level and response(12 weeks)
- Baseline vitamin D level and relapse free survival(up to 2 years)
- Variation of vitamin D level(4 weeks)