Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
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
- Hematopoietic and Lymphoid System Neoplasm
- Malignant Solid Neoplasm
- Stomatitis
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard of Care Mouthwash Group |
Patients receive standard of care mouthwash as needed on study. |
|
|
Experimental Methylene Blue Mouthwash Group |
Patients receive Methylene Blue mouthwash as needed on study. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05878405
- Status
- Completed
- Sponsor
- Mayo Clinic