Evidence map›Paper›PMID 28476132›Full record

Trial reportBMC cancer2017

Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study.

T Yokota, T Ogawa, S Takahashi, K Okami, T Fujii, K Tanaka, S Iwae, I Ota, T Ueda, N Monden and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02085460 (A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT02085460 phase2completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

TypeinterventionalSponsorOtsuka Pharmaceutical Co., Ltd.Ran2014 to 2015Enrolled94ConditionsHead and Neck CancerArmsPlacebo, 2% Rebamipide liquid, 4% Rebamipide liquid
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Guideline
  2. Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
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  8. A phase II study of HMB/Arg/Gln against oral mucositis induced by chemoradiotherapy for patients with head and neck cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
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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

23 authors at 20 institutions in 1 country.

T YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka, 411-8777, Japan. t.yokota@scchr.jp.ORCID 0000-0001-7327-7949
T OgawaDepartment of Otolaryngology-Head and Neck Surgery, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan.
S TakahashiDepartment of Medical Oncology, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
K OkamiDepartment of Otolaryngology, Center of Head and Neck Surgery, Tokai University, 143 Shimokasuya, Isehara, Japan.
T FujiiDepartment of Otolaryngology, Head and Neck Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, 537-8511, Japan.
K TanakaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Sayama, Osaka, 589-0014, Japan.
S IwaeDepartment of Head and Neck Cancer, Hyogo Cancer Center, Akashi, 673-8558, Japan.
I OtaDepartment of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashiharashi, 634-8522, Japan.
T UedaDepartment of Otorhinolaryngology-Head and Neck Surgery, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
N MondenDepartment of Head and Neck Surgery, Shikoku Cancer Center, Matsuyama, 791-0280, Japan.
K MatsuuraDepartment of Head and Neck Surgery, Miyagi Cancer Center, 47-1 Medeshimashiote, Natori, 981-1293, Japan.
H KojimaDepartment of Otorhinolaryngology, Jikei University School of Medicine, 3-19 Nishi-Shinbashi, Minato-ku, Tokyo, 105-0003, Japan.
S UedaMedical Oncology, Nara Hospital, Kindai University School of Medicine, 1248-1 Otoda-cho, Ikoma, Nara, 630-0293, Japan.
K SasakiHead and Neck, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba, 260-0801, Japan.
Y FujimotoDepartment of Otorhinolaryngology, Nagoya University, Graduate School of Medicine, 65 Tsurumai-cho, Shouwa-ku, Nagoya, Aichi, 466-8550, Japan.
Y HasegawaDepartment of Head and Neck Surgery, Aichi Cancer Center Hospital and Research Institute, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
T BeppuDivision of Head and Neck Surgery, Saitama Cancer Center, 780 Komuro, Inamachi, Kitaadachi-gun, Saitama, Japan.
H NishimoriDepartment of Hematology and Oncology, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.
S HiranoDepartment of Otolaryngology-Head and Neck Surgery, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
Y Naka, Headquarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd., Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo, 108-8242, Japan.
Y Matsushima, Headquarters of New Product Evaluation and Development, Otsuka Pharmaceutical Co., Ltd., Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo, 108-8242, Japan.
M FujiiDepartment of Otolaryngology, Eiju General Hospital, 2-23-16 Higashiueno, Taito-ku, Tokyo, 110-8645, Japan.
M TaharaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Otsuka (Japan) · JPAichi Cancer Center · JPChiba Cancer Center · JPEiju General Hospital · JPHiroshima University Hospital · JPHyogo Prefectural Cancer Center · JPJikei University School of Medicine · JPKindai University · JPKyoto University Hospital · JPMiyagi Prefectural Hospital Organization · JPNagoya University · JPNara Medical University · JPNara Medical University Hospital · JPNational Cancer Center Hospital East · JPOkayama University Hospital · JPOsaka International Cancer Institute · JPSaitama Cancer Center · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent preclinical and phase I studies have reported that rebamipide decreased the severity of chemoradiotherapy-induced oral mucositis in patients with oral cancer. This placebo-controlled randomized phase II study assessed the clinical benefit of rebamipide in reducing the incidence of severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (HNC).

methodsPatients aged 20-75 years with HNC who were scheduled to receive chemoradiotherapy were enrolled. Patients were randomized to receive rebamipide 2% liquid, rebamipide 4% liquid, or placebo. The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee.

resultsFrom April 2014 to August 2015, 97 patients with HNC were enrolled, of whom 94 received treatment. The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. The incidences of adverse events potentially related to the study drug were 16%, 26%, and 13% in the placebo, rebamipide 2%, and rebamipide 4% groups, respectively. There was no significant difference in treatment compliance among the groups.

conclusionsThe present phase II study suggests that mouth washing with rebamipide may be effective and safe for patients with HNC receiving chemoradiotherapy, and 4% liquid is the optimal dose of rebamipide.

trial registrationClinicalTrials.gov under the identifier NCT02085460 (the date of trial registration: March 11, 2014).

Indexed as

AdultAgedAlanineChemoradiotherapyDose-Response Relationship, DrugDouble-Blind MethodFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedQuinolonesStomatitisAlanineQuinolonesrebamipideChemoradiotherapyHead and neck cancerOral mucositisPlacebo-controlledRandomizedRebamipide liquid

Identifiers

PMID28476132
PMCPMC5420134
OpenAlexW2610510169

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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.