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

Study Overview
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Brief Summary
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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.

Official Title
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Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study

Conditions
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Stomatitis, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
* Other: Methylene Blue Oral Rinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active cancer diagnosis Admitted to the inpatient setting Grade 3-4 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Mouthwash Group<br>Patients receive standard of care mouthwash as needed on study. | Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse<br>* Given PO<br>* Other names: Dentoxol Mouthrinse;|
| Experimental: Methylene Blue Mouthwash Group<br>Patients receive Methylene Blue mouthwash as needed on study. | Other: Methylene Blue Oral Rinse<br>* Given PO<br>* Other names: MB Oral Rinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral pain | Pain will be assessed using the standard institutional numeric rating scale where pain level is quantified on a scale of 0 (no pain) to 10 (worst possible pain) pre- and post-intervention (3 times daily for 3 days). Last collected scores will be compared to baseline. | Baseline, 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the amount of oral intake | Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output | Baseline, 3 days | 
| Change in the amount of daily requirements of oral morphine equivalents | Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output | Baseline, 3 days |