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临床试验/NCT07042711
NCT07042711进行中(未招募)不适用

Effect of Vitamin D Supplementation on Therapeutic Response in Nasopharyngeal Cancer (NPC) Patients Undergoing Chemoradiation and Its Relation With IL-6

Indonesia University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Effect of Vitamin D Supplementation on therapeutic response in nasopharyngeal cancer (NPC) patients undergoing chemoradiation and its relation with IL-6

研究概览

简要总结

Nasopharyngeal cancer is the sixth most common cancer and the sixth leading cause of death in Indonesia. NPC is a radiosensitive cancer so radiotherapy is the basic therapy for NPC. Concurrent chemoradiotherapy (CCRT) with Intensity modulated radiotherapy (IMRT) is the standard therapy for locally advanced NPC. Vitamin D deficiency is common in patients with head and neck cancer including NPC. Several studies have shown better outcomes and fewer complications of therapy in patients with higher vitamin D levels. Inflammation plays an important role in tumor development and progression. The effect of vitamin D supplementation on cancerous and precancerous lesions shows that there is a potential for major changes in IL-6 levels.

By supplementing vitamin D in NPC patients with vitamin D deficiency before undergoing chemoradiation, it will increase the therapeutic response and reduce IL-6 levels (proinflammatory cytokines). Until now, there have been no studies evaluating the administration of vitamin D supplementation in NPC patients with vitamin D deficiency undergoing chemoradiation in Indonesia.

详细描述

According to the Global Cancer Observatory (Globocan) 2022, nasopharyngeal cancer (NPC) is the sixth most common cancer and the sixth leading cause of death among all cancers in Indonesia. The incidence of NPC varies across regions of the world, with the highest incidence for men and women detected in Southeast Asia (7.7 and 2.5 per 100,000 person-years, respectively), in Indonesia itself the NPC incidence rate is 10.7 per 100,000 person-years and the mortality rate is 7.7 per 100,000 person-years. NPC is a radiosensitive cancer so radiotherapy is the basic therapy for NPC. The outcome of NPC patient treatment has improved over the past decade, especially after the introduction of Concurrent chemoradiotherapy (CCRT) with Intensity modulated radiotherapy (IMRT) and induction chemotherapy. Patients who receive radiotherapy with IMRT will provide better therapeutic results with milder long-term side effects than conventional radiotherapy techniques. Vitamin D deficiency is more common in head and neck cancer patients compared to healthy populations. Vitamin D can downregulate the expression of nuclear factor kappa light chain enhancer of activated B cells (NF-κB) and also inhibit the inflammatory response mediated by immune cells through the vitamin D receptor (VDR) expressed on human cells. Several studies have shown the tumor suppressive effect of vitamin D through antitumor activity in various cancers. Vitamin D also has a role in potentiating antitumor activity through radiotherapy. IL-6 is a pro-inflammatory cytokine that plays an important role in the TME. Serum IL-6 levels in NPC patients increase and correlate with advanced stages. Low vitamin D levels before therapy are associated with worse outcomes and increased treatment-related complications, so it is important to manage vitamin D deficiency in NPC patients to improve the response to therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •NPC stage III-IVA who will undergo chemoradiation
  • •Have vitamin D deficiency (vitamin D level <30 ng/mL)
  • •Age > 18 years
  • •WHO ECOG performance status 0-2

排除标准

  • •Subject has autoimmune disease
  • •Subject is undergoing immunosuppressive therapy
  • •Patient routinely consumes vitamin D supplementation
  • •Experiencing other acute conditions (eg: severe infection)
  • •Subject cannot be evaluated (drop out, loss to follow up)

研究组 & 干预措施

Vitamin D Group

Experimental

NPC patients received capsules containing vitamin D or a placebo to the and neither patient nor researcher knows

干预措施: Placebo (Dietary Supplement)

Vitamin D Group

Experimental

NPC patients received capsules containing vitamin D or a placebo to the and neither patient nor researcher knows

干预措施: Vitamin D 5,000IU Oral Tablet (Dietary Supplement)

结局指标

主要结局

Effect of Vitamin D Supplementation on therapeutic response in nasopharyngeal cancer (NPC) patients undergoing chemoradiation and its relation with IL-6

时间窗: January 2025 - Juny 2025

Therapeutic response is evaluated using RECIST 1.1 criteria based on MRI findings, and categorized into favorable response (Complete Response \[CR\] and Partial Response \[PR\]) and poor response (Stable Disease \[SD\] and Progressive Disease \[PD\]). The main outcome is the difference in response between groups

次要结局

  • Effect of Vitamin D Supplementation on therapeutic response in nasopharyngeal cancer (NPC) patients undergoing chemoradiation and its relation with IL-6(January 2025 - Juny 2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Budi Wiweko

Clinical Professor

Indonesia University

研究点 (1)

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