Dataset Information

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 from baseline to day 2, World Health Organization OM grades, morphine equivalent daily doses, and adverse events. The trial was registered with ClinicalTrials.gov ID: NCT03469284.

Results

Sixty patients (mean age 43, range 22-62 years) completed the study. Compared with those who received CTx alone, those who received MB had a significant reduction of pain scores at day 2 of treatment (mean ± SD); 0.025%: 5.2 ± 2.9, 0.05%: 4.5 ± 2.9, 0.1%: 5.15 ± 2.6) and reduction of oral function burden scores (0.025%: 2.5 ± 1.55, 0.05%: 2.8 ± 1.7, 0.1%: 2.9 ± 1.60). No serious adverse events were noted, but eight patients reported burning sensation of the oral cavity with the first dose, and this caused one patient to discontinue therapy.

Conclusions

MB oral rinse showed significant pain reduction and improved oral functioning with minimal adverse effects.

Trial registration

ClinicalTrials.gov ID: NCT03469284.

SUBMITTER: Roldan CJ

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

REPOSITORIES: biostudies-literature

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Publications

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

Roldan Carlos J CJ Huh Billy B Song Juhee J Nieto Yago Y Osei Joyce J Chai Thomas T Nouri Kent K Koyyalagunta Lakshmi L Bruera Eduardo E

BMC medicine 20221103 1

<h4>Background</h4>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.<h4>Methods</h4>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). Inte ...[more]

PMID: 36324139

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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