Effects of an Oral Elemental Nutritional Supplement on Post-gastrectomy Body Weight Loss in Gastric Cancer Patients: A Randomized Controlled Clinical Trial
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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.
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.
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.
ED supplementation reduced postoperative weight loss in gastric cancer patients undergoing gastrectomy.
KeywordsGastric Cancer Patient Total Gastrectomy Body Weight Loss Distal Gastrectomy Postoperative Weight Loss
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.
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.
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.