title: Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients.
abstract: BACKGROUND
  A lipid emulsion composed of soybean oil (long-chain triglycerides, LCT), medium-chain triglycerides (MCT) and n-3 poly-unsaturated fatty acids (PUFAs) was evaluated for immune-modulation efficacy, safety, and tolerance in patients undergoing major surgery for gastric and colorectal cancer.
  
  
  METHODS
  In a prospective, randomized, double-blind study, 99 patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group, receiving the n-3 PUFAs enriched intravenous fat emulsion (IVFE), or the control group, receiving a lipid emulsion comprised of soybean oil and MCTs (0.8 - 1.5 g · kg-1 · day-1) as part of total parenteral nutrition (TPN) regimen from surgery (day -1) up to post-operative day 7. Safety and efficacy parameters were assessed on day -1 and post-operative visits on day 1, 3, and 7. Adverse events were documented daily and compared between the groups.
  
  
  RESULTS
  Pro-inflammatory markers, laboratory parameters, and adverse events did not differ prominently between the 2 groups, with the exception of net changes (day 7 minus day -1) of free fatty acids (FFAs), triglyceride, and high-density lipoprotein (HDL). Net decrease of FFAs was remarkably higher in the study group, while the net increase of triglyceride and decrease of HDL was significantly lower.
  
  
  CONCLUSIONS
  The n-3 PUFA-enriched IVFE showed improvements in lipid metabolism. In respect of efficacy, safety and tolerance both IVFE were comparable. In patients with severe stress, there is an inflammation-attenuating effect of n-3 PUFAs. Further, adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients.
  
  
  BACKGROUND
  US ClinicalTrials.gov NCT00798447.
authors.forename: Cheng-Jen
authors.initials: CJ
authors.lastname: Ma
authors.forename: Jin-Ming
authors.initials: JM
authors.lastname: Wu
authors.forename: Hsiang-Lin
authors.initials: HL
authors.lastname: Tsai
authors.forename: Ching-Wen
authors.initials: CW
authors.lastname: Huang
authors.forename: Chien-Yu
authors.initials: CY
authors.lastname: Lu
authors.forename: Li-Chu
authors.initials: LC
authors.lastname: Sun
authors.forename: Ying-Ling
authors.initials: YL
authors.lastname: Shih
authors.forename: Chao-Wen
authors.initials: CW
authors.lastname: Chen
authors.forename: Jui-Fen
authors.initials: JF
authors.lastname: Chuang
authors.forename: Ming-Hsun
authors.initials: MH
authors.lastname: Wu
authors.forename: Ming-Yang
authors.initials: MY
authors.lastname: Wang
authors.affiliation: Division of Gastroenterology and General Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No, 100 Tzyou 1st Road, Kaohsiung 807, Taiwan. linmt@ntu.edu.tw.
authors.forename: Ming-Tsan
authors.initials: MT
authors.lastname: Lin
authors.forename: Jaw-Yuan
authors.initials: JY
authors.lastname: Wang
mesh_terms: D000368:Aged; D015179:Colorectal Neoplasms / Q000601:surgery*; D004311:Double-Blind Method; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage*; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000601:surgery*
chemical_list: D005217:Fat Emulsions, Intravenous; D015525:Fatty Acids, Omega-3; D008055:Lipids