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

March 1, 2024 updated by: Mayo Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the effectiveness of methylene blue mouthwash on improving oral pain in patients with oral mucositis related to cancer and/or cancer treatment.

SECONDARY OBJECTIVE:

I. Evaluate for any changes in the amount of oral intake and daily requirements of oral morphine equivalents.

OUTLINE: Patients who are on standard of care mouthwash at time of enrollment are assigned to group I and patients who are not on standard of care mouthwash at time of enrollment are assigned to group II.

GROUP I: Patients receive standard of care (SOC) mouthwash orally (PO) on study.

GROUP II: Patients receive methylene blue (MB) mouthwash PO on study.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Regina M. Mackey, M.D.
          • Phone Number: 507-293-9793
        • Principal Investigator:
          • Regina M. Mackey, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oral pain
Time Frame: 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.
Baseline, 3 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Regina M Mackey, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-007588 (Other Identifier: Mayo Clinic in Rochester)
  • NCI-2023-03542 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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