Impact of Vitamin D on Therapeutic Respons in NPC Chemoradiated Patients

NCT07042711 | Active Not Recruiting

• 1 other identifier: CS01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

Vitamin D; Nasopharyngeal Cancer; NPC; Human Interleukin-6; Chemoradiation; Therapy; HIL-6; Radioteraphy

Outcome Measures

Primary Outcomes (1)

• 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

  January 2025 - Juny 2025

Secondary Outcomes (1)

• 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

Study Arms (1)

Vitamin D Group

EXPERIMENTAL

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

Interventions

Placebo DIETARY_SUPPLEMENT

Patients are given capsules that can contain either a placebo or Vitamin D.

Also known as: Control

Vitamin D Group

Vitamin D 5,000IU Oral Tablet DIETARY_SUPPLEMENT

Patients are given capsules that can contain either a placebo or Vitamin D.

Vitamin D Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr Cipto Mangunkusumo Hospital and Dharmais Cancer Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Vitamin D; Tablets

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Budi Wiweko, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 29, 2025
• Study Start: January 10, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)