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Pancreatic cancer
Effect of exercise therapy on sarcopenia in pancreatic cancer: a study protocol for a randomised controlled trial
  1. Kazunori Yoh1,
  2. Hiroki Nishikawa1,2,
  3. Hirayuki Enomoto1,
  4. Noriko Ishii1,
  5. Yoshinori Iwata1,
  6. Akio Ishii1,
  7. Yukihisa Yuri1,
  8. Yuho Miyamoto1,
  9. Kunihiro Hasegawa1,
  10. Chikage Nakano1,
  11. Ryo Takata1,
  12. Takashi Nishimura1,
  13. Nobuhiro Aizawa1,
  14. Yoshiyuki Sakai1,
  15. Naoto Ikeda1,
  16. Tomoyuki Takashima1,
  17. Hiroko Iijima1,
  18. Shuhei Nishiguchi1,2
  1. 1 Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
  2. 2 Centre for Clinical Research and Education, Hyogo College of Medicine, Nishinomiya, Japan
  1. Correspondence to Dr Hirayuki Enomoto; enomoto{at}hyo-med.ac.jp

Abstract

Introduction and purpose Sarcopenia is defined as a decrease in muscle mass and muscle strength, and it has been demonstrated to be an adverse predictor in numerous types of cancers. Exercise therapy (ET) carries multiple health benefits in several diseases. Despite these clinical benefits, there are limited data available regarding patients with pancreatic cancer (PC) undergoing ET. We aim to prospectively examine the effect of ET on sarcopenia in patients with PC.

Methods and analysis All clinical stages of PC can be included. When registering study subjects, a precise evaluation of the nutritional status and the daily physical activities performed will be undertaken individually, for each participant. Study participants will be randomly allocated into two groups: (1) the ET and standard therapy group and (2) the standard therapy group. Amelioration of sarcopenia at 3 months postrandomisation will be the primary endpoint. Muscle mass will be calculated using bioimpedance analysis. Sarcopenia will be defined based on the current Asian guidelines. Participants will be instructed to perform exercises with > 3 metabolic equivalents (mets; energy consumption in physical activities/resting metabolic rate) for 60 min/day and to perform exercises with > 23 mets/week. In the ET group, physical activities equal to or greater than walking for 60 min/day will be strongly recommended.

Ethics and dissemination The Institutional Review Board at Hyogo College of Medicine has approved this study protocol (approval no. 2772). The final data will be publicly announced. A report releasing the study results will be submitted for publication.

Trial registration number UMIN000029271; Pre-results.

  • cancer
  • clinical trials
  • gastrointestinal neoplasia
  • nutritional status
  • pancreatic cancer

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjgast-2017-000194

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    Footnotes

    • Contributors KY: designed the study and will write the initial draft of the manuscript. HN and HE: will do analysis and interpretation of the data, and assist in preparation of the manuscript. All other authors: will do data collection and interpretation, and will critically review the manuscript.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Provenance and peer review Not commissioned; externally peer reviewed.