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

Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05878405

Enrollment

Registered

2023-05-26

Start date

2023-06-06

Completion date

2024-12-06

Last updated

2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Stomatitis

Brief summary

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. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.

Interventions

OTHERAnti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Given PO

OTHERMethylene Blue Oral Rinse

Given PO

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Active cancer diagnosis * Admitted to the inpatient setting * Pain related to oral mucositis * Experiencing oropharyngeal pain * Able to provide informed consent

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in oral pain	Baseline, 3 days	Pain will be assessed using the standard institutional numeric rating scale where pain level is quantified on a scale of 0 (no pain) to 10 (worst possible pain) pre- and post-intervention (3 times daily for 3 days). Last collected scores will be compared to baseline.

Secondary

Measure	Time frame	Description
Change in the amount of oral intake	Baseline, 3 days	Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Change in the amount of daily requirements of oral morphine equivalents	Baseline, 3 days	Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026