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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05878405

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Stomatitis	Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse Other: Methylene Blue Oral Rinse	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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 Given PO Other Names: Dentoxol Dentoxol Mouthrinse
Experimental: Methylene Blue Mouthwash Group Patients receive Methylene Blue mouthwash as needed on study.	Other: Methylene Blue Oral Rinse Given PO Other Names: MB Oral Rinse

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

Given PO

Other Names:

Dentoxol

Dentoxol Mouthrinse

Experimental: Methylene Blue Mouthwash Group

Patients receive Methylene Blue mouthwash as needed on study.

Other: Methylene Blue Oral Rinse

Given PO

Other Names:

MB Oral Rinse

Outcome Measures

Primary Outcome Measures

Change in oral pain [Baseline, 3 days]
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.

Secondary Outcome Measures

Change in the amount of oral intake [Baseline, 3 days]
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Change in the amount of daily requirements of oral morphine equivalents [Baseline, 3 days]
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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