Evidence map›Paper›PMID 41950207›Full record

ArticlePloS one2026

Prevention of oral mucositis in patients undergoing cancer chemotherapy using betamethasone mouthwash: A multicenter randomized controlled trial protocol.

Sakiko Soutome, Tomofumi Hamada, Hiromi Nishi, Eiji Iwata, Hirokazu Nakahara, Toshiro Yamamoto, Tatsushi Matsumura, Masaya Nishikawa, Kei Tomihara, Koichiro Ueki and 12 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

22 authors.

Sakiko SoutomeDepartment of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.ORCID https://orcid.org/0000-0002-4646-587X
Tomofumi HamadaDepartment of Oral and Maxillofacial Surgery, Social Medical Corporation Hakuaikai Sagara Hospital, Kagoshima, Japan.
Hiromi NishiDepartment of General Dentistry, Hiroshima University Hospital, Hiroshima, Japan.
Eiji IwataDepartment of Oral and Maxillofacial Surgery, Kakogawa Central City Hospital, Hyogo, Japan.ORCID https://orcid.org/0000-0002-4010-8062
Hirokazu NakaharaDepartment of Dentistry and Oral Surgery, Osaka Metropolitan University Hospital, Osaka, Japan.
Toshiro YamamotoDepartment of Dental Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Tatsushi MatsumuraDepartment of Oral and Maxillofacial Surgery, Wakayama Medical University, Wakayama, Japan.ORCID https://orcid.org/0000-0002-0409-6252
Masaya NishikawaDepartment of Dentistry and Oral Surgery, Nishichita General Hospital, Aichi, Japan.
Kei TomiharaDivision of Oral and Maxillofacial Surgery, Niigata University Graduate School of Medical and Dental Science, Niigata, Japan.
Koichiro UekiDepartment of Oral and Maxillofacial Surgery, Division of Medicine, Interdisciplinary Graduate School, University of Yamanashi, Yamanashi, Japan.
Mamoru NodaDepartment of Endodontics, School of Dentistry, Faculties and Graduate Schools, Iwate Medical University, Iwate, Japan.
Makoto ShimanishiDepartment of Dental and Oral Surgery, Oji General Hospital, Hokkaido, Japan.
Madoka FunaharaSchool of Oral Health Sciences Faculty of Dentistry, Kyushu Dental University, Fukuoka, Japan.
Masami KawaharaLaboratory of Clinical Pharmacy, School of Pharmacy, Aichi Gakuin University, Aichi, Japan.
Yoshiko YamamuraDepartment of Oral and Maxillofacial Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan.
Shinpei MatsudaDepartment of Dentistry and Oral Surgery, Unit of Sensory and Locomotor Medicine, Division of Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Kensuke YoshidaDepartment of Drug Safety and Risk Management, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
Sanshiro KanazawaDepartment of Oral and Maxillofacial Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Minako OtsujiDentistry/Oral and Maxillofacial Surgery, Kagoshima City Hospital, Kagoshima, Japan.
Nagato NatsumeDivision of Research and Treatment for Oral Maxillofacial Congenital Anomalies, School of Dentistry, Aichi Gakuin University, Aichi, Japan.
Masahiro UmedaDivision of Research and Treatment for Oral Maxillofacial Congenital Anomalies, School of Dentistry, Aichi Gakuin University, Aichi, Japan.
Research Committee of the Japanese Society of Oral Care

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral mucositis is a frequent adverse effect of chemotherapy that significantly affects patients' quality of life and treatment continuity. Despite its clinical relevance, effective preventive strategies remain limited. This study aims to compare the efficacy and safety of betamethasone mouthwash with those of sodium gualenate hydrate mouthwash for preventing chemotherapy-induced oral mucositis.

methodsThis Phase II, multicenter, open-label, randomized controlled trial aims to enroll 296 adult patients (≥18 years) undergoing chemotherapy for solid tumors (excluding head and neck and hematological cancers). Participants will be randomized 1:1 into two arms: a betamethasone mouthwash (intervention) group and a sodium gualenate hydrate mouthwash (control) group. The primary outcome is the prevention of Grade 1 oral mucositis, assessed using the Common Terminology Criteria for Adverse Events v3.0 and v5.0. Secondary outcomes include prevention of Grade 2-3 oral mucositis, the incidence of oral candidiasis, and chemotherapy completion rates. Data will be analyzed using Kaplan-Meier survival curves, log-rank tests, and Cox regression models. EXPECTED OUTCOMES: This study aims to establish betamethasone mouthwash as an effective preventive strategy for potentially enhancing the quality of life of patients with cancer.

trial registrationThis study was registered with the Japan Registry of Clinical Trials on September 20, 2024 (jRCTs071240060).

Indexed as

Antineoplastic AgentsBetamethasoneMouthwashesNeoplasmsStomatitisAdultClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAntineoplastic AgentsBetamethasoneMouthwashes

Identifiers

PMID41950207
PMCPMC13061232

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Registered trials

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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.