Evidence map›Paper›PMID 42829889›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026

N-acetylcysteine mouthwash for prevention of oral mucositis in hematopoietic cell transplant recipients: a double-blind randomized controlled trial.

Motahareh Tahmasebi, Romina Kaveh-Ahangaran, Maryam Barkhordar, Mazda Rad-Malekshahi, Mohammad Vaezi, Leyla Sharifi Aliabadi, Mobina Sadat Zarabadi, Bita Shahrami

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07325383 (Evaluating the Safety and Efficacy of N-acetylcysteine Mouthwash on the Prevention of Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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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.

NCT07325383 phase3active not recruitingnot on this map

Evaluating the Safety and Efficacy of N-acetylcysteine Mouthwash on the Prevention of Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: a Double-blind Randomized Clinical Trial

TypeinterventionalSponsorTehran University of Medical SciencesRan2024 to 2026Enrolled106ConditionsOral Mucositis, Hematopoietic Stem Cell Transplantation (HSCT)ArmsN-Acetylcysteine 600mg/tab, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Motahareh TahmasebiDepartment of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0009-0001-2360-8065
Romina Kaveh-AhangaranCell Therapy and Hematopoietic Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0002-8158-3708
Maryam BarkhordarCell Therapy and Hematopoietic Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0002-8121-2819
Mazda Rad-MalekshahiDepartment of Pharmaceutical Biomaterials and Medical Biomaterials Research Center, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Mohammad VaeziHematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0002-3186-5491
Leyla Sharifi AliabadiHematology, Oncology and Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology, and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0002-7111-1483
Mobina Sadat ZarabadiCraniomaxillofacial Research Center, Tehran University of Medical Sciences, Tehran, Iran.ORCID http://orcid.org/0000-0001-9015-7105
Bita ShahramiDepartment of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. bita.shahrami@gmail.com.ORCID http://orcid.org/0000-0002-5383-782X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOral mucositis (OM) is a frequent and clinically important toxicity of conditioning therapy for hematopoietic cell transplantation (HCT). This trial evaluated whether prophylactic N-acetylcysteine (NAC) mouthwash reduces the incidence and severity of OM in HCT recipients.

methodsIn this single-center, double-blind, randomized, placebo-controlled trial, adults undergoing autologous or allogeneic HCT were assigned 1:1 to NAC mouthwash (600 mg every 6 h; 2400 mg/day) or matching placebo from the first day of conditioning until day +14 after transplantation or neutrophil engraftment, whichever occurred first. OM was assessed daily using the World Health Organization (WHO) Oral Toxicity Scale. The primary outcomes were the incidence of any OM and severe OM (WHO grades 3-4). Safety and exploratory predictors of OM were also evaluated.

resultsA total of 106 patients were randomized (NAC, n = 54; placebo, n = 52) and included in the intention-to-treat efficacy analysis. Any-grade OM occurred in 33/54 patients (61.1%) receiving NAC and 38/52 patients (73.1%) receiving placebo (P = 0.190). Severe OM was significantly less frequent with NAC than with placebo (3/54 [5.6%] vs. 13/52 [25.0%]; P = 0.006), and the overall distribution of WHO grades favored NAC (P = 0.046). NAC was well tolerated; gastrointestinal adverse events were mild and infrequent. In multivariable analysis, allogeneic HCT, myeloablative conditioning, suboptimal adherence, and placebo assignment were associated with higher odds of OM.

conclusionNAC mouthwash did not significantly reduce the overall incidence of OM but significantly reduced severe OM in adults undergoing HCT. Given its low cost, availability, and favorable tolerability, NAC mouthwash may be a practical supportive-care strategy for reducing clinically consequential mucosal toxicity. Multicenter trials with standardized formulations and patient-reported outcomes are warranted.

trial registrationClinicalTrials.gov identifier NCT07325383 (registered on November 16, 2025); Iranian Registry of Clinical Trials (IRCT20140818018842N42).

Indexed as

AcetylcysteineHematopoietic Stem Cell TransplantationMouthwashesStomatitisTransplantation ConditioningAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexYoung AdultAcetylcysteineMouthwashesHematopoietic cell transplantationMouthwashN-acetylcysteineOral mucositisRandomized controlled trialSupportive care

Identifiers

PMID42829889

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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.