Prevalence and impact of Vitamin D deficiency on the treatment outcomes of Head and Neck squamous cell carcinoma patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 561
- 试验地点
- 1
- 主要终点
- -Disease free survival.
研究概览
简要总结
The study intends to see the prevalence of Vitamin D deficiency and its impact on the treatment outcomes in head and neck squamous cell carcinoma patients.
As Vitamin D deficiency has been shown to be associated with various cancers in the literature and there are studies to show the protective role of Vitamin D against cancers in view of its immunomodulatory action.
This study will determine whether such an association is present in our population of head and neck cancers. And if so, we can preemptively start treating Vitamin D deficiency in our patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed, treatment naïve HNSCC patients.
- •Undergoing upfront surgery followed by adjuvant treatment (as indicated).
- •Willing to follow up in TMH.
排除标准
- •Recurrent cancer & Second Primary.
- •Nasopharyngeal carcinoma, metastasis of unknown origin.
- •Patients not giving consent for the study.
结局指标
主要结局
-Disease free survival.
时间窗: Vitamin D deficiency in the patients will be corrected with standard treatment protocol. | - Patients QOL will be accessed, prior to treatment, at treatment completion & at 1yr follow-up.
-Overall survival.
时间窗: Vitamin D deficiency in the patients will be corrected with standard treatment protocol. | - Patients QOL will be accessed, prior to treatment, at treatment completion & at 1yr follow-up.
-Prevalence of vitamin D deficiency.
时间窗: Vitamin D deficiency in the patients will be corrected with standard treatment protocol. | - Patients QOL will be accessed, prior to treatment, at treatment completion & at 1yr follow-up.
-Quality of life using FACT HN score.
时间窗: Vitamin D deficiency in the patients will be corrected with standard treatment protocol. | - Patients QOL will be accessed, prior to treatment, at treatment completion & at 1yr follow-up.
次要结局
- -To know the role of vitamin D deficiency in the pathophysiology of squamous cell carcinoma of Head and Neck and throw light on the treatment outcome.(Vitamin D deficiency in the patients will be corrected in due course with standard treatment protocol.)