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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT05878405 (opens ClinicalTrials.gov in a new tab)Other id22-007588Other idNCI-2023-03542Other id22-007588
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
49 participants (actual)
Sponsor
Mayo Clinic · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
6 Jun 2023
Primary completion
6 Dec 2024
Completion
6 Dec 2024
First posted
26 May 2023
Last update posted
30 Apr 2025
Conditions
Hematopoietic and Lymphoid System Neoplasm · Malignant Solid Neoplasm · Stomatitis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 3

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

    NCT05878405

    6 Jun 2023 to 6 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth RinseOther
  • Methylene Blue Oral RinseOther

Arms2

  • Active comparator

    Standard of Care Mouthwash Group

    Patients receive standard of care mouthwash as needed on study.

  • Experimental

    Methylene Blue Mouthwash Group

    Patients receive Methylene Blue mouthwash as needed on study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in oral pain

    Time frame · Baseline, 3 days

    Registry 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.

Secondary outcomes(2)

  1. Change in the amount of oral intake

    Time frame · Baseline, 3 days

    Registry description

    Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output

  2. Change in the amount of daily requirements of oral morphine equivalents

    Time frame · Baseline, 3 days

    Registry description

    Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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