N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial

Terence T. Sio, Miran J. Blanchard, Paul J. Novotny, Samir H Patel, Jean Claude M. Rwigema, Levi D. Pederson, Lisa A. McGee, Mauricio E. Gamez, Grant R. Seeger, James A Jr. Martenson, Yvonne Grover, Michelle A. Neben Wittich, Yolanda I. Garces, Robert Foote, Robert Clell Miller, Michele Y Halyard

Research output: Contribution to journalArticle

Abstract

Objective: To determine whether N-acetylcysteine rinse was safe and could improve thickened secretions and dry mouth during and after radiotherapy. Patients and Methods: We designed a prospective pilot double-blind, placebo-controlled randomized clinical trial (Alliance MC13C2). Adult patients (age ≥18 years) were enrolled if they underwent chemoradiotherapy (≥60 Gy). Patients initiated testing rinse within 3 days of starting radiotherapy. With swish-and-spit, they received 10% N-acetylcysteine (2500 mg daily) or placebo rinse solution 5 times daily during radiotherapy and 2 weeks postradiotherapy. The primary aim was to evaluate N-acetylcysteine in improvement of saliva viscosity with the Groningen Radiotherapy-Induced Xerostomia questionnaire. Secondary aims included evaluating xerostomia improvement by the same questionnaire and with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Head and Neck-35 Questions survey and adverse-event profiles. The type I error rate was 20%. Results: Thirty-two patients undergoing chemoradiotherapy were enrolled. Baseline characteristics were balanced for placebo (n=17) and N-acetylcysteine (n=15). N-acetylcysteine was better for improving sticky saliva (area under curve, P=.12). Scores of multiple secondary end points favored N-acetylcysteine, including sticky saliva daytime (P=.04), daytime and total xerostomia (both P=.02), pain (P=.18), and trouble with social eating (P=.15). Repeated measures models confirmed the findings. Taste was a major dissatisifer for N-acetylcysteine rinse; however, both testing rinses were safe and well tolerated overall. Conclusion: Our pilot data showed that N-acetylcysteine rinse was safe and provided strong evidence of potential efficacy for improving thickened saliva and xerostomia by patient-reported outcome. A confirmatory phase 3 trial is required. Trial Registration: clinicaltrials.gov Identifier: NCT02123511

Original languageEnglish (US)
Pages (from-to)1814-1824
Number of pages11
JournalMayo Clinic proceedings
Volume94
Issue number9
DOIs
StatePublished - Sep 1 2019

ASJC Scopus subject areas

  • Medicine(all)

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    Sio, T. T., Blanchard, M. J., Novotny, P. J., Patel, S. H., Rwigema, J. C. M., Pederson, L. D., McGee, L. A., Gamez, M. E., Seeger, G. R., Martenson, J. A. J., Grover, Y., Neben Wittich, M. A., Garces, Y. I., Foote, R., Miller, R. C., & Halyard, M. Y. (2019). N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial. Mayo Clinic proceedings, 94(9), 1814-1824. https://doi.org/10.1016/j.mayocp.2019.03.031