Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Cancinoma (NPC) | Nasopharyngeal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Vitamin D 5,000IU Oral Tablet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin D Group
- description
- NPC patients received capsules containing vitamin D or a placebo to the and neither patient nor researcher knows
- interventionNames
- Dietary Supplement: Placebo
- Dietary Supplement: Vitamin D 5,000IU Oral Tablet
Primary outcomes (1)
- measure
- Effect of Vitamin D Supplementation on therapeutic response in nasopharyngeal cancer (NPC) patients undergoing chemoradiation and its relation with IL-6
- timeFrame
- January 2025 - Juny 2025
- description
- 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
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available