title: Effects of an Oral Elemental Nutritional Supplement on Post-gastrectomy Body Weight Loss in Gastric Cancer Patients: A Randomized Controlled Clinical Trial.
abstract: 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.
authors.affiliation: Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Japan. imamurahiroshisakai@yahoo.co.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.affiliation: Department of Surgery, Osaka National Hospital, Osaka, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.affiliation: Department of Surgery, Osaka Police Hospital, Osaka, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Kishi
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Surgery, Yao Municipal Hospital, Osaka, Japan.
authors.forename: Jin
authors.initials: J
authors.lastname: Matsuyama
authors.affiliation: Department of Surgery, Ikeda Municipal Hospital, Osaka, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Akamaru
authors.affiliation: Department of Surgery, Sakai Municipal Hospital, Osaka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
authors.affiliation: Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.
authors.forename: Ryohei
authors.initials: R
authors.lastname: Kawabata
authors.affiliation: Department of Surgery, Kaizuka City Hospital, Osaka, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Kawada
authors.affiliation: Department of Pharmacy, Osaka General Medical Center, Osaka, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Fujiwara
authors.affiliation: Department of Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Japan.
authors.forename: Tomono
authors.initials: T
authors.lastname: Kawase
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Fukui
authors.affiliation: Department of Pharmacy, Osaka General Medical Center, Osaka, Japan.
authors.forename: Mari
authors.initials: M
authors.lastname: Takagi
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takeno
authors.affiliation: Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Shimokawa
mesh_terms: D000368:Aged; D005260:Female; D005526:Food, Formulated; D005743:Gastrectomy; D006801:Humans; D008297:Male; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000601:surgery*; D016896:Treatment Outcome; D015431:Weight Loss