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Trial Title:
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients with Cancer
NCT ID:
NCT05878405
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Stomatitis
Conditions: Official terms:
Neoplasms
Mucositis
Stomatitis
Anti-Infective Agents
Anti-Bacterial Agents
Anti-Inflammatory Agents
Analgesics
Methylene Blue
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
Description:
Given PO
Arm group label:
Standard of Care Mouthwash Group
Other name:
Dentoxol
Other name:
Dentoxol Mouthrinse
Intervention type:
Other
Intervention name:
Methylene Blue Oral Rinse
Description:
Given PO
Arm group label:
Methylene Blue Mouthwash Group
Other name:
MB Oral Rinse
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Rosa Gomez
Phone:
507-255-1603
Email:
Gomez.Rosa@mayo.edu
Contact backup:
Last name:
Regina M. Mackey, M.D.
Start date:
June 6, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05878405
https://www.mayo.edu/research/clinical-trials
