Clinical trial · Interventional
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
NCT05878405CI-TRIAL-00089095completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse | Other | — | UNRESOLVED |
| Methylene Blue Oral Rinse | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Mouthwash Group
- description
- Patients receive standard of care mouthwash as needed on study.
- interventionNames
- Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
- type
- EXPERIMENTAL
- label
- Methylene Blue Mouthwash Group
- description
- Patients receive Methylene Blue mouthwash as needed on study.
- interventionNames
- Other: Methylene Blue Oral Rinse
Primary outcomes (1)
- measure
- Change in oral pain
- timeFrame
- Baseline, 3 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.