Hiroshi Imamura1, Kazuhiro Nishikawa2, Kentaro Kishi3, Kentaro Inoue4, Jin Matsuyama5, Yusuke Akamaru6, Yutaka Kimura7, Shigeyuki Tamura8, Ryohei Kawabata9, Junji Kawada10, Yoshiyuki Fujiwara11, Tomono Kawase12, Junichi Fukui4, Mari Takagi11, Atsushi Takeno8, Toshio Shimokawa13. 1. Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Japan. imamurahiroshisakai@yahoo.co.jp. 2. Department of Surgery, Osaka National Hospital, Osaka, Japan. 3. Department of Surgery, Osaka Police Hospital, Osaka, Japan. 4. Department of Surgery, Kansai Medical University, Hirakata, Japan. 5. Department of Surgery, Yao Municipal Hospital, Osaka, Japan. 6. Department of Surgery, Ikeda Municipal Hospital, Osaka, Japan. 7. Department of Surgery, Sakai Municipal Hospital, Osaka, Japan. 8. Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan. 9. Department of Surgery, Osaka Rosai Hospital, Osaka, Japan. 10. Department of Surgery, Kaizuka City Hospital, Osaka, Japan. 11. Department of Pharmacy, Osaka General Medical Center, Osaka, Japan. 12. Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Japan. 13. Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
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.
RCT Entities:
BACKGROUND: Post-gastrectomy weight loss is associated with deterioration in quality of life, and influences the long-term prognosis of gastric cancerpatients. 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 cancerpatients undergoing gastrectomy.