NCT07435415

Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

A Phase I Pilot Study of Tumor Local Injection Methylene Blue Combined With Radiation for Radiation Resistance Local Recurrent Head and Neck Cancer Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the effectiveness of Methylene Blue (MB) as a radiosensitizer in treating head and neck squamous cell carcinoma (HNSCC) that has recurred locally and is resistant to radiation therapy. It will also assess the safety of Methylene Blue. The main questions it aims to answer are: Does Methylene Blue improve the outcomes for patients with recurrent HNSCC receiving radiation therapy? What side effects do participants experience while receiving Methylene Blue? Participants will: Receive weekly injections of Methylene Blue or placebo into the tumor over six weeks. Undergo six weeks of concurrent radiation therapy. Be monitored regularly for treatment effects and document any side effects experienced during the trial. This single-center clinical trial intends to recruit 10 eligible patients diagnosed with locoregional recurrence of HNSCC that is resistant to previous radiotherapy.

Conditions

• Head and Neck Cancer
• Local Recurrent Tumor

Interventions

Type	Name	Description
DRUG	Methylene Blue (50 mg/10ml)	1. Methylene blue (50mg/10mL): Volume: 2 mL, 5 mL, 8 mL and 10mL are used for intratumoral injections in different lesion sizes. Frequency: weekly 2. Radiation dose: 50-60 Gy for target lesions

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Taiwan