Evidence map›Paper›PMID 26887378›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

Multicenter phase II study of an oral care program for patients with head and neck cancer receiving chemoradiotherapy.

Tomoya Yokota, Hiroyuki Tachibana, Tetsuhito Konishi, Takashi Yurikusa, Satoshi Hamauchi, Kensuke Sakai, Masaya Nishikawa, Miho Suzuki, Yayoi Naganawa, Tomoka Hagihara and 8 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
3.8field-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.

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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Systematic review of basic oral care 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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  6. 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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  17. Chemoradiotherapy for high-risk stage II laryngeal cancer.International journal of clinical oncology · 2020
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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

18 authors at 8 institutions in 1 country.

Tomoya YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. t.yokota@scchr.jp.
Hiroyuki TachibanaDivision of Radiation Oncology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Tetsuhito KonishiDivision of Dentistry, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Takashi YurikusaDivision of Dental and Oral Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Satoshi HamauchiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Kensuke SakaiSakai Dental Clinic, 6-7 Hayato-cho, Showa-ku, Nagoya, 466-0833, Japan.
Masaya NishikawaOral and Maxillofacial Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.
Miho SuzukiDivision of Dental and Oral Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Yayoi NaganawaDivision of Dentistry, Head and Neck Surgery, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Tomoka HagiharaDivision of Pharmacy, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Hiromi TsumakiDepartment of Nursing, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Tomo KuboDepartment of Nursing, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Maho SatoDepartment of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Masataka TaguriDepartment of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Satoshi MoritaInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
Toru EguchiSunstar Shizuoka Institute, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Kaoru KubotaDepartment of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School Hospital Cancer Center, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Sadamoto ZendaDivision of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Shizuoka Cancer Center · JPAichi Cancer Center · JPNational Cancer Center Hospital East · JPYokohama City University · JPKyoto University Hospital · JPNagoya University · JPNippon Medical School Hospital · JPSunstar (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis multicenter phase II trial assessed the clinical benefit of a multidisciplinary oral care program in reducing the incidence of severe chemoradiotherapy-induced oral mucositis (OM).

methodsPatients with head and neck cancer (HNC) who were scheduled to receive definitive or postoperative chemoradiotherapy were enrolled. The oral care program included routine oral screening by dentists and a leaflet containing instructions regarding oral care, nutrition, and lifestyle. Oral hygiene and oral care were evaluated continuously during and after the course of chemoradiotherapy. The primary endpoint was the incidence of grade ≥3 OM assessed by certified medical staff according to the Common Terminology Criteria of Adverse Events version 3.0.

resultsFrom April 2012 to December 2013, 120 patients with HNC were enrolled. Sixty-four patients (53.3 %) developed grade ≥3 OM (i.e., functional/symptomatic). The incidence of grade ≤1 OM at 2 and 4 weeks after radiotherapy completion was 34.2 and 67.6 %, respectively. Clinical examination revealed that 51 patients (42.5 %) developed grade ≥3 OM during chemoradiotherapy. The incidence of grade ≤1 OM at 2 and 4 weeks after radiotherapy completion was 54.7 and 89.2 %, respectively. The incidences of grade 3 infection and pneumonitis throughout chemoradiotherapy were <5 %. Only 6.7 % of patients had unplanned breaks in radiotherapy, and 99.2 % completed treatment.

conclusionsA systematic oral care program alone is insufficient to decrease the incidence of severe OM in patients with HNC being treated with chemoradiotherapy. However, systematic oral care programs may indirectly improve treatment compliance by decreasing infection risk. TRIAL REGISTRATION NUMBER: UMIN000006660.

Indexed as

AdultAgedChemoradiotherapyFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedStomatitisYoung AdultChemoradiotherapyHead and neck cancerMultidisciplinaryOral careOral mucositis

Identifiers

PMID26887378
OpenAlexW2279336817

What OpenQuestion holds

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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.