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Effects of an Oral Elemental Nutritional Supplement on Post-gastrectomy Body Weight Loss in Gastric Cancer Patients: A Randomized Controlled Clinical Trial

  • Gastrointestinal Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Post-gastrectomy weight loss is associated with deterioration in quality of life, and influences the long-term prognosis of gastric cancer patients. We conducted a prospective, randomized controlled, open-label study to examine whether an oral elemental diet (Elental®, Ajinomoto Pharmaceuticals, Tokyo, Japan; hereafter referred to as ED) prevents postoperative weight loss in post-gastrectomy patients.

Methods

Patients were randomly divided to receive the ED or control diet. The ED group received 300 kcal of ED plus their regular diet for 6–8 weeks after surgery, starting from the day the patient started a soft rice or equivalent diet after surgery, while the control group received the regular diet alone. The primary endpoint was the percentage of body weight loss (%BWL) from the presurgical body weight to that at 6–8 weeks after surgery. Secondary endpoints were dietary adherence, nutrition-related blood parameters, and adverse events.

Results

This study included 112 patients in eight hospitals. The mean treatment compliance rate in the ED group was 68.7 ± 30.4 % (median 81.2 %). The %BWL was significantly different between the ED and control groups (4.86 ± 3.72 vs. 6.60 ± 4.90 %, respectively; p = 0.047). In patients who underwent total gastrectomy, the %BWL was significantly different between the two groups (5.03 ± 3.65 vs. 9.13 ± 5.43 %, respectively; p = 0.012). In multivariate analysis, ED treatment, surgery type, and preoperative performance status were independently associated with %BWL. No significant differences were observed in the other clinical variables.

Conclusions

ED supplementation reduced postoperative weight loss in gastric cancer patients undergoing gastrectomy.

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Acknowledgment

The authors would like to thank all KSES collaborators, investigators, and patients for their participation and contribution to this study; Manabu Suzuki, PhD, and Yoshiki Kurose, employees of the Medical Science Department, Ajinomoto Pharmaceuticals Co., Ltd, for providing technical help in data management and writing assistance; Prof. Setsuko Anami, PhD, Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Doshisha Women’s College of Liberal Arts, Kyotanabe, Kyoto, Japan, for her clinical review of adverse events, and proofing and approving the final version of manuscript; Ajinomoto Pharmaceuticals Co., Ltd for providing meeting room facilities; and Nicholas D. Smith, PhD, of Edanz Group Ltd, for providing editorial assistance.

Author Contributions

Conceived and designed the study: Hiroshi Imamura and Ryohei Kawabata. Participated in data acquisition: Hiroshi Imamura, Kazuhiro Nishikawa, Kentaro Kishi, Kentaro Inoue, Jin Matsuyama, Yusuke Akamaru, Yutaka Kimura, Shigeyuki Tamura, Ryohei Kawabata, Junji Kawada, Yoshiyuki Fujiwara, Tomono Kawase, Junichi Fukui, Mari Takagi, and Atsushi Takeno. Statistical analysis and interpretation of data: Hiroshi Imamura. Statistical analysis of data: Toshio Shimokawa. Drafted the article: Hiroshi Imamura. Proofed and approved the final manuscript: Hiroshi Imamura, Kazuhiro Nishikawa, Kentaro Kishi, Yusuke Akamaru, Yutaka Kimura, Shigeyuki Tamura, Ryohei Kawabata, Yoshiyuki Fujiwara, Tomono Kawase, Junichi Fukui, Mari Takagi, Atsushi Takeno, and Toshio Shimokawa. All authors had access to the data and jointly decided to submit the manuscript.

Disclosures

Hiroshi Imamura, Kazuhiro Nishikawa, Kentaro Kishi, Kentaro Inoue, Jin Matsuyama, Yusuke Akamaru, Yutaka Kimura, Shigeyuki Tamura, Ryohei Kawabata, Junji Kawada, Yoshiyuki Fujiwara, Tomono Kawase, Junichi Fukui, Mari Takagi, Atsushi Takeno, and Toshio Shimokawa declare they have no potential conflicts of interest.

Author information

Authors and Affiliations

  1. Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Japan

    Hiroshi Imamura MD & Tomono Kawase MD

  2. Department of Surgery, Osaka National Hospital, Osaka, Japan

    Kazuhiro Nishikawa MD

  3. Department of Surgery, Osaka Police Hospital, Osaka, Japan

    Kentaro Kishi MD

  4. Department of Surgery, Kansai Medical University, Hirakata, Japan

    Kentaro Inoue MD & Junichi Fukui MD

  5. Department of Surgery, Yao Municipal Hospital, Osaka, Japan

    Jin Matsuyama MD

  6. Department of Surgery, Ikeda Municipal Hospital, Osaka, Japan

    Yusuke Akamaru MD

  7. Department of Surgery, Sakai Municipal Hospital, Osaka, Japan

    Yutaka Kimura MD

  8. Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan

    Shigeyuki Tamura MD & Atsushi Takeno MD

  9. Department of Surgery, Osaka Rosai Hospital, Osaka, Japan

    Ryohei Kawabata MD

  10. Department of Surgery, Kaizuka City Hospital, Osaka, Japan

    Junji Kawada MD

  11. Department of Pharmacy, Osaka General Medical Center, Osaka, Japan

    Yoshiyuki Fujiwara MD & Mari Takagi MD

  12. Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan

    Toshio Shimokawa PhD

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  1. Hiroshi Imamura MD
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  2. Kazuhiro Nishikawa MD
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  9. Ryohei Kawabata MD
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  13. Junichi Fukui MD
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  14. Mari Takagi MD
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  16. Toshio Shimokawa PhD
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Corresponding author

Correspondence to Hiroshi Imamura MD.

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Trial Registration

UMIN000008056 (University Hospital Medical Information Network Clinical Trials Registry).

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Imamura, H., Nishikawa, K., Kishi, K. et al. Effects of an Oral Elemental Nutritional Supplement on Post-gastrectomy Body Weight Loss in Gastric Cancer Patients: A Randomized Controlled Clinical Trial. Ann Surg Oncol 23, 2928–2935 (2016). https://doi.org/10.1245/s10434-016-5221-4

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  • DOI: https://doi.org/10.1245/s10434-016-5221-4

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