Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03542 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22-007588 | Other Identifier | Mayo Clinic in Rochester |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Mouthwash Group | Active Comparator | Patients receive standard of care mouthwash as needed on study. |
|
| Methylene Blue Mouthwash Group | Experimental | Patients receive Methylene Blue mouthwash as needed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse | Other | Given PO |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Regina M Mackey, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Methylene Blue Oral Rinse | Other | Given PO |
|
|
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output |
| Baseline, 3 days |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided