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Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205)

  • Yusuke Suwa
  • Jun Watanabe
  • Mitsuyoshi Ota
  • Shinsuke Suzuki
  • Hirokazu Suwa
  • Kazuteru Watanabe
  • Shuji Saito
  • Koutaro Nagamine
  • Masashi Momiyama
  • Atsushi Ishibe
  • Yusuke Saigusa
  • Takeharu Yamanaka
  • Itaru Endo
Original Article
  • 8 Downloads

Abstract

Purpose

Capeox is widely used as an adjuvant chemotherapy regimen of colorectal cancer that does not require central vein catheter insertion. However, oxaliplatin-related vascular pain with peripheral administration is a major adverse event. We assessed the preventive effect of Celecoxib on oxaliplatin-related vascular pain.

Methods

A multicenter study of the Yokohama Clinical Oncology Group (YCOG) in Japan. This study was an open label, randomized non-comparative phase II study between Capeox without Celecoxib (C+ Group) and with it (C− group). The primary endpoint was the appearance frequency of grade ≥ 2 vascular pain according to the Verbal Rating Scale (VRS).

Results

Between October 2012 and February 2014, 81 patients were recruited to this study and randomly divided into 2 groups: 38 patients in the C− group and 39 patients in the C+ group. Four cases were excluded at the analysis stage because they had not received the allocated intervention. The rate of grade ≥ 2 vascular pain was 55.3% in the C− group and 53.8% in the C+ group (p = 1.000).

Conclusions

Celecoxib was unable to prevent oxaliplatin-related vascular pain in this study. However, it may be able to decrease the vascular pain that patients already have.

Keywords

Oxaliplatin Vascular pain Celecoxib Colon cancer Capeox 

Notes

Acknowledgements

I wish to thank all of the doctors, pharmacists, and nurses concerned with this trial.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Yusuke Suwa
    • 1
  • Jun Watanabe
    • 2
  • Mitsuyoshi Ota
    • 2
  • Shinsuke Suzuki
    • 1
  • Hirokazu Suwa
    • 3
  • Kazuteru Watanabe
    • 4
  • Shuji Saito
    • 5
  • Koutaro Nagamine
    • 6
  • Masashi Momiyama
    • 4
  • Atsushi Ishibe
    • 1
  • Yusuke Saigusa
    • 7
  • Takeharu Yamanaka
    • 7
  • Itaru Endo
    • 1
  1. 1.Department of Gastroenterological SurgeryYokohama City University Graduate School of MedicineYokohamaJapan
  2. 2.Gastroenterological CenterYokohama City University Medical CenterYokohamaJapan
  3. 3.Department of SurgeryYokosuka Kyosai HospitalYokosukaJapan
  4. 4.Department of SurgeryNTT Medical Center TokyoTokyoJapan
  5. 5.Department of SurgeryNational Hospital Organization Yokohama Medical CenterYokohamaJapan
  6. 6.Department of SurgeryYokosuka Municipal Citizen’s HospitalYokosukaJapan
  7. 7.Department of BiostatisticsYokohama City UniversityYokohamaJapan

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