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

Last updated: April 28, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

3

Condition

Mucositis

Neoplasms

Treatment

Methylene Blue Oral Rinse

Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Clinical Study ID

NCT05878405
22-007588
NCI-2023-03542
22-007588
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active cancer diagnosis

  • Admitted to the inpatient setting

  • Pain related to oral mucositis

  • Experiencing oropharyngeal pain

  • Able to provide informed consent

Exclusion

Exclusion Criteria:

  • Pediatric age (under 18 years old)

  • Pregnant or nursing women

  • Any contraindication to methylene blue including severe hypersensitivity tomethylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD)due to the risk of hemolytic anemia

Study Design

Total Participants: 49
Treatment Group(s): 2
Primary Treatment: Methylene Blue Oral Rinse
Phase: 3
Study Start date:
June 06, 2023
Estimated Completion Date:
December 06, 2024

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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