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Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

NCT07435415 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • China Medical University, Taiwan

    collaborator OTHER

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435415 on ClinicalTrials.gov