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NCT Number: NCT05878405

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

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.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Other

Given PO

Other names: Dentoxol, Dentoxol Mouthrinse

Methylene Blue Oral Rinse

Other

Given PO

Other names: MB Oral Rinse

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 26, 2023
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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