Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05878405
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in oral pain', 'timeFrame': 'Baseline, 3 days', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in the amount of oral intake', 'timeFrame': 'Baseline, 3 days', 'description': 'Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output'}, {'measure': 'Change in the amount of daily requirements of oral morphine equivalents', 'timeFrame': 'Baseline, 3 days', 'description': 'Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid System Neoplasm', 'Malignant Solid Neoplasm', 'Stomatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active cancer diagnosis\n* Admitted to the inpatient setting\n* Pain related to oral mucositis\n* Experiencing oropharyngeal pain\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pediatric age (under 18 years old)\n* Pregnant or nursing women\n* 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'}, 'identificationModule': {'nctId': 'NCT05878405', 'briefTitle': 'Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '22-007588'}, 'secondaryIdInfos': [{'id': 'NCI-2023-03542', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '22-007588', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Mouthwash Group', 'description': 'Patients receive standard of care mouthwash as needed on study.', 'interventionNames': ['Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse']}, {'type': 'EXPERIMENTAL', 'label': 'Methylene Blue Mouthwash Group', 'description': 'Patients receive Methylene Blue mouthwash as needed on study.', 'interventionNames': ['Other: Methylene Blue Oral Rinse']}], 'interventions': [{'name': 'Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse', 'type': 'OTHER', 'otherNames': ['Dentoxol', 'Dentoxol Mouthrinse'], 'description': 'Given PO', 'armGroupLabels': ['Standard of Care Mouthwash Group']}, {'name': 'Methylene Blue Oral Rinse', 'type': 'OTHER', 'otherNames': ['MB Oral Rinse'], 'description': 'Given PO', 'armGroupLabels': ['Methylene Blue Mouthwash Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Regina M Mackey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}