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NCT05878405 | Recruiting | Hematopoietic and Lymphoid System Neoplasm


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

Mayo Clinic

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.

Condition or disease

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Stomatitis

Intervention/treatment

Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Methylene Blue Oral Rinse

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
Actual Study Start Date : May 30, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025
Arm Intervention/treatment

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

Experimental: Methylene Blue Mouthwash Group

Patients receive Methylene Blue mouthwash as needed on study.

Other: Methylene Blue Oral Rinse

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

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