Evidence map›Paper›PMID 31405750›Full record

Trial reportMayo Clinic proceedings2019

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 Martenson and 6 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Mayo Clinic proceedings, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02123511 (A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02123511 phase2completednot on this map

A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies

TypeinterventionalSponsorMayo ClinicRan2014 to 2018Enrolled34ConditionsMucositis, Oral Complications, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the LipArmsacetylcysteine, placebo, quality-of-life assessment, questionnaire administration
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. A systematic review of salivary gland hypofunction and/or xerostomia induced by non-surgical cancer therapies: prevention strategies.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  2. N-acetylcysteine mouthwash for prevention of oral mucositis in hematopoietic cell transplant recipients: a double-blind randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Trial
  3. Trial
  4. Trial
  5. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
  6. Article
  7. Article
  8. Article
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  10. Article
  11. Review
  12. Antioxidants (Basel, Switzerland) · 2021
    Review
  13. Review
  14. Article
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Terence T SioDepartment of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ.
Miran J BlanchardDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN; Sanford Roger Maris Cancer Center, Fargo, ND.
Paul J NovotnyDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.
Samir H PatelDepartment of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ.
Jean-Claude M RwigemaDepartment of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ.
Levi D PedersonDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.
Lisa A McGeeDepartment of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ.
Mauricio E GamezDepartment of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ.
Grant R SeegerDepartment of Radiation Oncology, Altru Cancer Center, Grand Forks, ND.
James A MartensonDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN.
Yvonne GroverDepartment of Pharmacy, Mayo Clinic Hospital, Phoenix, AZ.
Michelle A Neben WittichDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN; Division of General Internal Medicine, Mayo Clinic, Rochester, MN.
Yolanda I GarcesDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN.
Robert L FooteDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN.
Robert C MillerDepartment of Radiation Oncology, Mayo Clinic, Jacksonville, FL.
Michele Y HalyardDepartment of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ. Electronic address: MHalyard@mayo.edu.
Mayo Clinic Hospital · USMayo Clinic in Arizona · USMayo Clinic · USAltru Health System · USFargo VA Health Care System · USMayo Clinic in Florida · US

Funding

Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI NIH HHS U10 CA180790NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA232760
6 · The paper itself

Abstract

objectiveTo determine whether N-acetylcysteine rinse was safe and could improve thickened secretions and dry mouth during and after radiotherapy. PATIENTS AND

methodsWe 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%.

resultsThirty-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.

conclusionOur 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 registrationclinicaltrials.gov Identifier: NCT02123511.

Indexed as

AcetylcysteineAgedChemoradiotherapyDouble-Blind MethodFemaleFollow-Up StudiesHead and Neck NeoplasmsHumansMaleMiddle AgedMouth MucosaMouthwashesMucositisPatient Reported Outcome MeasuresPatient SafetyPilot ProjectsAcetylcysteineMouthwashes

Identifiers

PMID31405750
PMCPMC6742495
OpenAlexW2967220225

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.