An interventional study of Placebo and Vitamin D 5,000IU Oral Tablet in Nasopharyngeal Cancinoma (NPC), sponsored by Indonesia University. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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.
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.
240 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 198 interventional studies indexed under Nasopharyngeal Neoplasms.
Browse Nasopharyngeal Neoplasms studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NPC patients received capsules containing vitamin D or a placebo to the and neither patient nor researcher knows
Dietary Supplement: Placebo · Dietary Supplement: Vitamin D 5,000IU Oral Tablet
Patients are given capsules that can contain either a placebo or Vitamin D.
Also known as: Control
Patients are given capsules that can contain either a placebo or Vitamin D.
Effect of Vitamin D Supplementation on therapeutic response in nasopharyngeal cancer (NPC) patients undergoing chemoradiation and its relation with IL-6
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
Time frame: January 2025 - Juny 2025
Effect of Vitamin D Supplementation on therapeutic response in nasopharyngeal cancer (NPC) patients undergoing chemoradiation and its relation with IL-6
To compare the mean change in serum IL-6 levels (pg/mL) from Pre-chemoradiation to post-chemoradiation between participants receiving placebo and those receiving vitamin D supplementation.
Time frame: January 2025 - Juny 2025
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indonesia University