title: A Phase III trial to evaluate the effect of perioperative nutrition enriched with eicosapentaenoic acid on body weight loss after total gastrectomy for T2-T4a gastric cancer.
abstract: This randomized Phase III trial will evaluate whether perioperative nutrition enriched with eicosapentaenoic acid can prevent body weight loss after total gastrectomy for gastric cancer. The patients who enroll in this study will be randomly assigned to Group A: no supplementation with oral nutrients (standard diet) or Group B: standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery. For both groups, patients will undergo total gastrectomy with Roux-en Y reconstruction. The extent of dissection will principally follow the third edition of the Gastric Cancer Treatment Guideline published by the Japanese Gastric Cancer Association. When patients are diagnosed with pathological Stage II or III disease, adjuvant chemotherapy with S-1 will be initiated within 6 weeks after surgery and administered for 1 year. The primary endpoint will be the body weight loss at 1 and 3 months after surgery (double primary endpoints). The secondary endpoints will be the relative performance of the supplement, loss of lean body mass at 1 and 3 months after surgery, the lowest serum albumin level, quality of life, the incidence of surgical morbidity and mortality, and the incidence of surgical site infection.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiki
authors.forename: Masataka
authors.initials: M
authors.lastname: Taguri
authors.forename: Takeshi
authors.initials: T
authors.lastname: Sano
authors.forename: Souya
authors.initials: S
authors.lastname: Nunobe
authors.forename: Hideki
authors.initials: H
authors.lastname: Taniguchi
authors.forename: Ryoji
authors.initials: R
authors.lastname: Fukushima
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Cho
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
mesh_terms: D000328:Adult; D000368:Aged; D000713:Anastomosis, Roux-en-Y; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D019587:Dietary Supplements; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage*; D005260:Female; D005743:Gastrectomy; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D059035:Perioperative Period; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012107:Research Design; D013274:Stomach Neoplasms / Q000473:pathology* / Q000601:surgery*; D005641:Tegafur / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D015118:Eicosapentaenoic Acid