TY - JOUR
T1 - Methylene blue for intractable pain from oral mucositis related to cancer treatment
T2 - a randomized phase 2 clinical trial
AU - Roldan, Carlos J.
AU - Huh, Billy
AU - Song, Juhee
AU - Nieto, Yago
AU - Osei, Joyce
AU - Chai, Thomas
AU - Nouri, Kent
AU - Koyyalagunta, Lakshmi
AU - Bruera, Eduardo
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Cancer therapy
KW - Methylene blue Oral Rinse
KW - Oral mucositis
UR - http://www.scopus.com/inward/record.url?scp=85141074773&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85141074773&partnerID=8YFLogxK
U2 - 10.1186/s12916-022-02579-8
DO - 10.1186/s12916-022-02579-8
M3 - Article
C2 - 36324139
AN - SCOPUS:85141074773
SN - 1741-7015
VL - 20
JO - BMC medicine
JF - BMC medicine
IS - 1
M1 - 377
ER -