Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

Plain-language guide to NCT07435415: early phase 1 interventional trial of Methylene blue (non-peptide stack partner), 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT07435415
Phase: early phase 1
Status: active, not recruiting
Start: 2025-08-01
Completion (planned or actual): 2026-12-31
Participants: 10 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Head and Neck Cancer; Local Recurrent Tumor
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (early phase 1) is built around Methylene blue (non-peptide stack partner).

It will also assess the safety of Methylene Blue.

It had 1 arm (groups): Methylene blue intratumoral injection combined with radiation (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 10 planned participants were the target.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: . Histologically confirmed squamous cell carcinoma of head and neck. . Locoregional recurrence. . After standard treatment of R/M HNSCC. . ECOG performance status ≤2. . Age ≧20 years old; and life expectancy of at least 12 weeks.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: . presence of central nervous system (cns) metastases; . concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia; . documented hypersensitivity to methylene blue compound or compounds of similar chemical or biologic composition.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-08-01 with completion listed for 2026-12-31.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Any unexpected severe adverse event resulting from the combination treatment (time frame: "through study completion, an average of 1 year").

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Methylene blue (non-peptide stack partner) in 10 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.