title: Randomized clinical trial comparing standard diet with perioperative oral immunonutrition in total gastrectomy for gastric cancer.
abstract: BACKGROUND
  Total gastrectomy for gastric cancer is associated with excessive weight loss and decreased calorie intake. Nutritional support using eicosapentaenoic acid modulates immune function and limits catabolism in patients with advanced cancer, but its impact in the perioperative period is unclear.
  
  
  METHODS
  This was a randomized phase III clinical trial of addition of eicosapentaenoic acid-rich nutrition to a standard diet in patients having total gastrectomy for gastric cancer. Patients were randomized to either a standard diet or standard diet with oral supplementation of an eicosapentaenoic acid (ProSure®), comprising 600 kcal with 2·2 g eicosapentaenoic acid, for 7 days before and 21 days after surgery. The primary endpoint was percentage bodyweight loss at 1 and 3 months after surgery.
  
  
  RESULTS
  Of 127 eligible patients, 126 were randomized; 124 patients (61 standard diet, 63 supplemented diet) were analysed for safety and 123 (60 standard diet, 63 supplemented diet) for efficacy. Across both groups, all but three patients underwent total gastrectomy with Roux-en-Y reconstruction. Background factors were well balanced between the groups. Median compliance with the supplement in the immunonutrition group was 100 per cent before and 54 per cent after surgery. The surgical morbidity rate was 13 per cent in patients who received a standard diet and 14 per cent among those with a supplemented diet. Median bodyweight loss at 1 month after gastrectomy was 8·7 per cent without dietary supplementation and 8·5 per cent with eicosapentaenoic acid enrichment (P = 0·818, adjusted P = 1·000). Similarly, there was no difference between groups in percentage bodyweight loss at 3 months (P = 0·529, adjusted P = 1·000).
  
  
  CONCLUSIONS
  Immunonutrition based on an eicosapentaenoic acid-enriched oral diet did not reduce bodyweight loss after total gastrectomy for gastric cancer compared with a standard diet. Registration number: UMIN000006380 ( http://www.umin.ac.jp/).
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Ida
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Hiki
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Centre, Yokohama, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Cho
authors.affiliation: Department of Biostatistics and Epidemiology, Yokohama City University Medical Centre, Yokohama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Sakamaki
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Centre, Nagoya, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Ito
authors.affiliation: Departments of Surgery, Osaka General Medical Centre, Osaka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Fujitani
authors.affiliation: Division of Gastroenterological Surgery, Chiba Cancer Centre, Chiba, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Takiguchi
authors.affiliation: Division of Gastroenterological Surgery, Saitama Cancer Centre, Saitama, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Kawashima
authors.affiliation: Departments of Surgery, Osaka Medical Centre, Osaka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Nishikawa
authors.affiliation: Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Sasako
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Centre, Yokohama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Aoyama
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Honda
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Centre, Yokohama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Nunobe
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Centre, Yokohama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yoshikawa
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001835:Body Weight; D019587:Dietary Supplements; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage*; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage; D010535:Laparoscopy / Q000379:methods; D008297:Male; D008875:Middle Aged; D018529:Nutritional Support / Q000379:methods; D019990:Perioperative Care / Q000379:methods; D013274:Stomach Neoplasms / Q000178:diet therapy / Q000601:surgery*; D055815:Young Adult
chemical_list: D007155:Immunologic Factors; D015118:Eicosapentaenoic Acid