NCT07042711

Impact of Vitamin D on Therapeutic Respons in NPC Chemoradiated Patients

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Patients are given capsules that can contain either a placebo or Vitamin D.
DIETARY_SUPPLEMENT	Vitamin D 5,000IU Oral Tablet	Patients are given capsules that can contain either a placebo or Vitamin D.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2025-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: Indonesia