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 language | English (US) |
|---|---|
| Pages (from-to) | 1814-1824 |
| Number of pages | 11 |
| Journal | Mayo Clinic proceedings |
| Volume | 94 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2019 |
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ASJC Scopus subject areas
- Medicine(all)
Cite this
N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2) : A Double-Blind Randomized Clinical Trial. / Sio, Terence T.; Blanchard, Miran J.; Novotny, Paul J.; Patel, Samir H.; Rwigema, Jean Claude M.; Pederson, Levi D.; McGee, Lisa A.; Gamez, Mauricio E.; Seeger, Grant R.; Martenson, James A.; Grover, Yvonne; Neben Wittich, Michelle A.; Garces, Yolanda Isabel; Foote, Robert L.; Miller, Robert C.; Halyard, Michele Y.
In: Mayo Clinic proceedings, Vol. 94, No. 9, 01.09.2019, p. 1814-1824.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2)
T2 - A Double-Blind Randomized Clinical Trial
AU - Sio, Terence T.
AU - Blanchard, Miran J.
AU - Novotny, Paul J.
AU - Patel, Samir H.
AU - Rwigema, Jean Claude M.
AU - Pederson, Levi D.
AU - McGee, Lisa A.
AU - Gamez, Mauricio E.
AU - Seeger, Grant R.
AU - Martenson, James A.
AU - Grover, Yvonne
AU - Neben Wittich, Michelle A.
AU - Garces, Yolanda Isabel
AU - Foote, Robert L.
AU - Miller, Robert C.
AU - Halyard, Michele Y.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - 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
AB - 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
UR - http://www.scopus.com/inward/record.url?scp=85070264424&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85070264424&partnerID=8YFLogxK
U2 - 10.1016/j.mayocp.2019.03.031
DO - 10.1016/j.mayocp.2019.03.031
M3 - Article
C2 - 31405750
AN - SCOPUS:85070264424
VL - 94
SP - 1814
EP - 1824
JO - Mayo Clinic Proceedings
JF - Mayo Clinic Proceedings
SN - 0025-6196
IS - 9
ER -