title: Multi-institutional prospective feasibility study to explore tolerability and efficacy of oral nutritional supplements for patients with gastric cancer undergoing gastrectomy (CCOG1301).
abstract: BACKGROUND
  Postoperative malnutrition after gastrectomy is deemed inevitable, which could have prejudicial influence on survival for gastric cancer patients. A prospective feasibility study was conducted to evaluate the efficacy of postoperative oral nutritional supplements.
  
  
  METHODS
  Stage I-III gastric cancer patients who underwent distal or total gastrectomy received oral administration of Racol®NF (Otsuka Pharmaceutical Factory, Japan), a liquid enteral nutritional formula, as a supplement to regular meals. Racol®NF administration at a recommended dosage of 400 kcal/400 ml per day was started within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was ratio of the weight loss at 3 months postoperatively to the preoperative body weight (body weight loss ratio). Secondary end points were the adherence to Racol®NF therapy and changes in body composition.
  
  
  RESULTS
  One hundred eighteen patients were registered before surgery, 82 of whom were eligible for efficacy analyses. The average rate of body weight loss after 3 months postoperatively was 8.3%. The mean daily intake of Racol®NF was 211 ml. There was a significant correlation between adherence to Racol®NF therapy and body weight loss ratio (P < 0.001). Adherence to Racol®NF therapy was the only factor that correlated with the body weight loss ratio among all clinical characteristics by the multiple linear regression analysis (P = 0.007).
  
  
  CONCLUSIONS
  Oral nutritional supplementation with Racol®NF led to a significant reduction in body weight loss for gastrectomized patients who tolerated more than 200 ml of the nutrient per day compared with those who could not tolerate this amount.
authors.affiliation: Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. kobadai@med.nagoya-u.ac.jp.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Konan Kosei Hospital, Konan, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ishigure
authors.affiliation: Department of Surgery, Komaki City Hospital, Komaki, Japan.
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Mochizuki
authors.affiliation: Department of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakayama
authors.affiliation: Department of Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sakai
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.affiliation: Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Okazaki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kojima
authors.affiliation: Department of Surgery, Gifu Prefectural Tajimi Hospital, Tajimi, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Kajikawa
authors.affiliation: Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.affiliation: Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kodera
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004750:Enteral Nutrition / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects*; D006801:Humans; D008297:Male; D044342:Malnutrition / Q000209:etiology / Q000517:prevention & control*; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000601:surgery*
keywords: Gastrectomy; Gastric cancer; Malnutrition; Oral nutritional supplements