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

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Abstract

Purpose

This 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).

Methods

Patients 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.

Results

From 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.

Conclusions

A 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

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Acknowledgments

The authors thank Drs. Takeshi Kodaira, Yusuke Onozawa, Chiyoko Makita, Tomomi Hikosaka, Yukihiko Oshima, and Akiko Todaka for patient enrollment and Mr. Akihiro Sudo for oral care equipment management. This study was supported by a grant from the National Cancer Center Research and Development Fund (23-A-30) and by Sunstar Inc. Equipment for oral care was supplied by Sunstar Inc.

Author information

Authors and Affiliations

  1. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Tomoya Yokota & Satoshi Hamauchi

  2. Division of Radiation Oncology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan

    Hiroyuki Tachibana

  3. Division of Dentistry, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Tetsuhito Konishi

  4. Division of Dental and Oral Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Takashi Yurikusa & Miho Suzuki

  5. Sakai Dental Clinic, 6-7 Hayato-cho, Showa-ku, Nagoya, 466-0833, Japan

    Kensuke Sakai

  6. Oral and Maxillofacial Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan

    Masaya Nishikawa

  7. Division of Dentistry, Head and Neck Surgery, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan

    Yayoi Naganawa

  8. Division of Pharmacy, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Tomoka Hagihara

  9. Department of Nursing, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Hiromi Tsumaki

  10. Department of Nursing, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan

    Tomo Kubo

  11. Department of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

    Maho Sato & Masataka Taguri

  12. Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

    Satoshi Morita

  13. Sunstar Shizuoka Institute, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Toru Eguchi

  14. Department 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

    Kaoru Kubota

  15. Division of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Sadamoto Zenda

Authors
  1. Tomoya Yokota
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  2. Hiroyuki Tachibana
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  3. Tetsuhito Konishi
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  4. Takashi Yurikusa
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  5. Satoshi Hamauchi
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  6. Kensuke Sakai
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  7. Masaya Nishikawa
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  8. Miho Suzuki
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  9. Yayoi Naganawa
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  10. Tomoka Hagihara
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  11. Hiromi Tsumaki
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  12. Tomo Kubo
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  13. Maho Sato
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  14. Masataka Taguri
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  15. Satoshi Morita
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  16. Toru Eguchi
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  17. Kaoru Kubota
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  18. Sadamoto Zenda
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Corresponding author

Correspondence to Tomoya Yokota.

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Conflict of interest

Tomoya Yokota serves in an advisory role for AstraZeneca, Merck Serono, and Bristol-Myers Squibb, and has received lecture fees from Merck Serono. Toru Eguchi is an employee of Sunstar Inc. Sunstar Inc. had no control over the interpretation, writing, or publication of this work.

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Yokota, T., Tachibana, H., Konishi, T. et al. Multicenter phase II study of an oral care program for patients with head and neck cancer receiving chemoradiotherapy. Support Care Cancer 24, 3029–3036 (2016). https://doi.org/10.1007/s00520-016-3122-5

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  • DOI: https://doi.org/10.1007/s00520-016-3122-5

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