{"preliminary_commentary":{"by_channel":{"bluesky_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT03469284","nct_id":"NCT03469284","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03469284. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.","label":"Group 1 (lower dose methylene blue, standard of care)","type":"EXPERIMENTAL"},{"description":"Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.","label":"Group 2 (medium dose methylene blue, standard of care)","type":"EXPERIMENTAL"},{"description":"Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.","label":"Group 3 (higher dose methylene blue, standard of care)","type":"EXPERIMENTAL"},{"description":"Patients receive standard of care therapy.","label":"Group 4 (standard of care)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-02-03","type":"ACTUAL"},"conditions":["Malignant Neoplasm","Oral Pain","Stomatitis"],"enrollment":{"count":69,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Best Practice","otherNames":["standard of care","standard therapy"],"type":"OTHER"},{"name":"Methylene Blue","otherNames":["Azul de Metileno","Azul Metile","Blu di Metilene","CI Basic Blue 9","CI-52015","Collubleu","Colour Index No. 52015","Desmoidpillen","Methylenum Caeruleum","Methylthioninii Chloridum","Methylthioninium Chloride","Schultz No. 1038","Tetramethylthionine Chloride Trihydrate","Urolene Blue","Vitableu"],"type":"DRUG"},{"name":"Methylene Blue","otherNames":["Azul de Metileno","Azul Metile","Blu di Metilene","CI Basic Blue 9","CI-52015","Collubleu","Colour Index No. 52015","Desmoidpillen","Methylenum Caeruleum","Methylthioninii Chloridum","Methylthioninium Chloride","Schultz No. 1038","Tetramethylthionine Chloride Trihydrate","Urolene Blue","Vitableu"],"type":"DRUG"},{"name":"Methylene Blue","otherNames":["Azul de Metileno","Azul Metile","Blu di Metilene","CI Basic Blue 9","CI-52015","Collubleu","Colour Index No. 52015","Desmoidpillen","Methylenum Caeruleum","Methylthioninii Chloridum","Methylthioninium Chloride","Schultz No. 1038","Tetramethylthionine Chloride Trihydrate","Urolene Blue","Vitableu"],"type":"DRUG"}],"last_update":"2023-04-25","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"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","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-02-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool","timeFrame":"Baseline up to day 7"}],"references":[{"citation":"Roldan CJ, Huh B, Song J, Nieto Y, Osei J, Chai T, Nouri K, Koyyalagunta L, Bruera E. Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial. BMC Med. 2022 Nov 3;20(1):377. doi: 10.1186/s12916-022-02579-8.","pmid":"36324139","type":"DERIVED"}],"start_date":{"date":"2019-02-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)","url":"https://clinicaltrials.gov/study/NCT03469284"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03469284"}