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Local Injection Methylene Blue Combined With Radiation in HNSCC Patients | Clinical Trials | Clareo Health

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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

NCT07435415•China Medical University Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. . Histologically confirmed squamous cell carcinoma of head and neck.
•2. . Locoregional recurrence.
•3. . After standard treatment of R/M HNSCC.
•4. . Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI).
•5. . Lesion selection criteria - at least 1 lesion to be injected must be measurable and greater than or equal to 1.5 cm and longest diameter not exceed 10 cm in principle.
•6. . ECOG performance status ≤2.
•7. . Age ≧20 years old; and life expectancy of at least 12 weeks.
•8. . Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
•9. . Must not have received anticancer therapy used with an antineoplastic intent, including chemotherapy, immunotherapy, biologic, or any investigational therapy within 14 days prior to the first dose of study drug.
•10. . No history of allergic reactions attributed to methylene blue.
+2 more criteria

Exclusion Criteria

•1. . Presence of central nervous system (CNS) metastases.
•2. . The organ function measured within 14 days prior to study entry as defined below: Absolute neutrophil count (ANC) less than 1,000/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤40 ml/min.
•3. . Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
•4. . Documented hypersensitivity to methylene blue compound or compounds of similar chemical or biologic composition.
•5. . Pregnant or lactating women.

Locations (1)

China medical university hospital

Taichung, Taiwan, Taiwan

Key Dates

Start Date

August 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

June 30, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Head and Neck CancerLocal Recurrent Tumor

Interventions

Methylene Blue (50 mg/10ml)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

Inclusion Criteria

Exclusion Criteria

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