MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)

What Was Tested

The trial (phase 2) is built around Methylene blue (non-peptide stack partner).

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Group 4 (standard of care) (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP 4: Patients receive standard of care therapy.

After completion of study treatment, patients are followed up at 1, 2, 7, and 30 days.

Who Took Part

Enrollment: 69 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: Patients with a current diagnosis of oral mucositis. Voluntary written consent.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: patients with known allergy to mb; pregnant or lactating patients; patients who are cognitively impaired and unable to consent for the study.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-02-28 with completion listed for 2022-02-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool (time frame: Baseline up to day 7).

It also tracked 4 secondary outcomes, for example Change in Oral Function Burden (OFB) Scores, World Health Organization Oral Mucositis Severity Grades and Pain Duration.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 69 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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