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

NCT ID: NCT05878405

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Stomatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care Mouthwash Group

Patients receive standard of care mouthwash as needed on study.

Group Type ACTIVE_COMPARATOR

Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Intervention Type OTHER

Given PO

Methylene Blue Mouthwash Group

Patients receive Methylene Blue mouthwash as needed on study.

Group Type EXPERIMENTAL

Methylene Blue Oral Rinse

Intervention Type OTHER

Given PO

Interventions

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Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse

Given PO

Intervention Type OTHER

Methylene Blue Oral Rinse

Given PO

Intervention Type OTHER

Other Intervention Names

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Dentoxol Dentoxol Mouthrinse MB Oral Rinse

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Regina M Mackey, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2023-03542

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-007588

Identifier Type: OTHER

Identifier Source: secondary_id

22-007588

Identifier Type: -

Identifier Source: org_study_id

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