Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial.

ABSTRACT:

Background

Oral mucositis (OM) in patients receiving cancer therapy is thus far not well managed with standard approaches. We aimed to assess the safety and effectiveness of methylene blue (MB) oral rinse for OM pain in patients receiving cancer therapy.

Methods

In this randomized, single-blind phase 2 clinical trial, patients were randomized to one of four arms: MB 0.025%+conventional therapy (CTx) (n = 15), MB 0.05%+CTx (n = 14), MB 0.1%+CTx (n = 15), or CTx alone (n = 16). Intervention groups received MB oral rinse every 6 h for 2 days with outcomes measured at days 1-2; safety was evaluated up to 30 days. The primary outcome measured change in the pain numeric rating scale (0-10) from baseline to day 2. Secondary outcome measured change in oral function burden scores fro

SUBMITTER: Roldan CJ 

PROVIDER: S-EPMC9632023 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature