Back to resultsMethylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
Primary Purpose
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Stomatitis
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
Methylene Blue Oral Rinse
Sponsored by
About this trial
This is an interventional supportive care trial for Hematopoietic and Lymphoid System Neoplasm
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Mouthwash Group
Methylene Blue Mouthwash Group
Arm Description
Patients receive standard of care mouthwash as needed on study.
Patients receive Methylene Blue mouthwash as needed on study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05878405
Brief Title
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
Official Title
Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Stomatitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Mouthwash Group
Arm Type
Active Comparator
Arm Description
Patients receive standard of care mouthwash as needed on study.
Arm Title
Methylene Blue Mouthwash Group
Arm Type
Experimental
Arm Description
Patients receive Methylene Blue mouthwash as needed on study.
Intervention Type
Other
Intervention Name(s)
Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
Other Intervention Name(s)
Dentoxol, Dentoxol Mouthrinse
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Methylene Blue Oral Rinse
Other Intervention Name(s)
MB Oral Rinse
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Change in oral pain
Description
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.
Time Frame
Baseline, 3 days
Secondary Outcome Measure Information:
Title
Change in the amount of oral intake
Description
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Time Frame
Baseline, 3 days
Title
Change in the amount of daily requirements of oral morphine equivalents
Description
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Time Frame
Baseline, 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina M Mackey, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina M. Mackey, M.D.
Phone
507-293-9793
First Name & Middle Initial & Last Name & Degree
Regina M. Mackey, M.D.
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
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