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

NCT05878405 | Completed Phase 3

• 2 other identifiers: 22-007588NCI-2023-03542
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm; Stomatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 days

Secondary Outcomes (2)

• Change in the amount of oral intake

  Baseline, 3 days

• Change in the amount of daily requirements of oral morphine equivalents

  Baseline, 3 days

Study Arms (2)

Standard of Care Mouthwash Group

ACTIVE COMPARATOR

Patients receive standard of care mouthwash as needed on study.

Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Methylene Blue Mouthwash Group

EXPERIMENTAL

Patients receive Methylene Blue mouthwash as needed on study.

Other: Methylene Blue Oral Rinse

Interventions

Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse OTHER

Given PO

Also known as: Dentoxol, Dentoxol Mouthrinse

Standard of Care Mouthwash Group

Methylene Blue Oral Rinse OTHER

Given PO

Also known as: MB Oral Rinse

Methylene Blue Mouthwash Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active cancer diagnosis
• Admitted to the inpatient setting
• Pain related to oral mucositis
• Experiencing oropharyngeal pain
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stomatitis

Interventions

Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Regina M Mackey, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 26, 2023
• Study Start: June 6, 2023
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

US (1)