Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer.

It had two arms (groups): Standard of Care Mouthwash Group (active comparator) and Methylene Blue Mouthwash Group (experimental).

Patients receive standard of care mouthwash as needed on study.

Patients receive Methylene Blue mouthwash as needed on study.

The registry classes the interventions as other.

Who Took Part

The registry lists 49 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Active cancer diagnosis. Admitted to the inpatient setting. Pain related to oral mucositis. Experiencing oropharyngeal pain. Able to provide informed consent.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: pediatric age (under 18 years old); pregnant or nursing women; any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2023-06-06 with completion listed for 2024-12-06.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Change in oral pain (time frame: Baseline, 3 days).

It also tracked 2 secondary outcomes, for example Change in the amount of oral intake and Change in the amount of daily requirements of oral morphine equivalents.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Methylene blue (non-peptide stack partner) in 49 people.

The trial is marked completed; 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.