MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)

Phase 2 Completed 69 enrolled M.D. Anderson Cancer Center

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2019-02-28
Primary completion: 2022-02-03
Completion: 2022-02-03

Outcome

Met primary endpoint

paper Compared with those who received CTx alone, those who received MB had a significant reduction of pain scores at day 2 of treatment PMID 36324139 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylene Blue	Diagnostic / imaging agent	0.025 %	Oral
Subject	Methylene Blue	Diagnostic / imaging agent	0.05 %	Oral
Subject	Methylene Blue	Diagnostic / imaging agent	0.1 %	Oral