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

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Stomatitis; Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse; Other: Methylene Blue Oral Rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT05878405

NCI-2023-03542 (Registry Identifier)

22-007588 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Standard of Care Mouthwash Group

Active Comparator group

Description:

Patients receive standard of care mouthwash as needed on study.

Treatment:

Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Methylene Blue Mouthwash Group

Experimental group

Description:

Patients receive Methylene Blue mouthwash as needed on study.

Treatment:

Other: Methylene Blue Oral Rinse