At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
Methylene Blue +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial Comparing 4 Intervention Arms, Including 3 Different Concentrations of Methylene Blue Oral Rinse Combined With Conventional Therapy and Conventional Therapy, in Patients With Intractable Pain Associated With Oral Mucositis
In Brief
A Phase 2 clinical trial evaluating Best Practice and Methylene Blue for Malignant Neoplasm and 2 related conditions. Completed, enrolled 69 participants across 1 site.
Detailed Summary
This phase II trial studies how well methylene blue works in treating patients with cancer and pain associated with oral mucositis. Methylene blue may relieve pain associated with oral mucositis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Neoplasm, Oral Pain, Stomatitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartFeb 2019
Primary CompletionFeb 2022
TodayJul 2026
First PostedMar 19, 2018
Enrollment StartFeb 28, 2019
Primary CompletionFeb 3, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.3 years ago
Interventions
Best Practiceother
Given standard of care therapy
Methylene Bluedrug
Given lower dose PO
Methylene Bluedrug
Given medium dose PO
Methylene Bluedrug
Given higher dose PO