@article{ebee67d213634e86b05b73ad0556e8f8,
title = "N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial",
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",
author = "Sio, {Terence T.} and Blanchard, {Miran J.} and Novotny, {Paul J.} and Patel, {Samir H.} and Rwigema, {Jean Claude M.} and Pederson, {Levi D.} and McGee, {Lisa A.} and Gamez, {Mauricio E.} and Seeger, {Grant R.} and Martenson, {James A.} and Yvonne Grover and {Neben Wittich}, {Michelle A.} and Garces, {Yolanda I.} and Foote, {Robert L.} and Miller, {Robert C.} and Halyard, {Michele Y.}",
note = "Funding Information: Grant Support: Research reported in this publication was supported by the NCI Community Oncology Research Program Cancer Prevention and Symptom Intervention Pilot Project Fund and the National Cancer Institute (NCI) of the National Institutes of Health under Award Number U10CA189823 (to the Alliance for Clinical Trials in Oncology NCI Community Oncology Research Program Grant) and U10CA180790. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding sources had no role in any aspect of this research project. Grant Support: Research reported in this publication was supported by the NCI Community Oncology Research Program Cancer Prevention and Symptom Intervention Pilot Project Fund and the National Cancer Institute (NCI) of the National Institutes of Health under Award Number U10CA189823 (to the Alliance for Clinical Trials in Oncology NCI Community Oncology Research Program Grant) and U10CA180790. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding sources had no role in any aspect of this research project. We are grateful to the clinical and research staff and the patients who assisted with and participated in this trial. They are from Mayo Clinic in Rochester, MN (18 patients); Mayo Clinic in Phoenix, AZ (13 patients); and Altru Cancer Center in Grand Forks, ND (3 patients). Sunstar Americas, Inc, (Schaumburg, IL) provided the mucoadherent delivery diluent solutions that were used for both arms. Grant Support: Research reported in this publication was supported by the NCI Community Oncology Research Program Cancer Prevention and Symptom Intervention Pilot Project Fund and the National Cancer Institute (NCI) of the National Institutes of Health under Award Number U10CA189823 (to the Alliance for Clinical Trials in Oncology NCI Community Oncology Research Program Grant) and U10CA180790. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding sources had no role in any aspect of this research project. Publisher Copyright: {\textcopyright} 2019 Mayo Foundation for Medical Education and Research",
year = "2019",
month = sep,
doi = "10.1016/j.mayocp.2019.03.031",
language = "English (US)",
volume = "94",
pages = "1814--1824",
journal = "Mayo Clinic Proceedings",
issn = "0025-6196",
publisher = "Elsevier Science",
number = "9",
}