Print Send My Information

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care Mouthwash Group 		Patients receive standard of care mouthwash as needed on study.
  • Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
    Given PO
    Other names:
    • Dentoxol
    • Dentoxol Mouthrinse
Experimental
Methylene Blue Mouthwash Group 		Patients receive Methylene Blue mouthwash as needed on study.
  • Other: Methylene Blue Oral Rinse
    Given PO
    Other names:
    • MB Oral Rinse

Recruiting Locations

More Details

NCT ID
NCT05878405
Status
Completed
Sponsor
Mayo Clinic

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center