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
Journal
Nutrition Journal
Journal Volume
14
Journal Issue
1
Date Issued
2015
Author(s)
Ma C.-J.
Tsai H.-L.
Huang C.-W.
Lu C.-Y.
Sun L.-C.
Shih Y.-L.
Chen C.-W.
Chuang J.-F.
Wang M.-Y.
Wang J.-Y.
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. ? 2015 Ma et al.; licensee BioMed Central.
SDGs
Other Subjects
alanine aminotransferase; albumin; aspartate aminotransferase; bilirubin; C reactive protein; cholesterol; gamma glutamyltransferase; glucose; high density lipoprotein; insulin; interleukin 6; lipid emulsion; low density lipoprotein; omega 3 fatty acid; soybean oil; triacylglycerol; tumor necrosis factor alpha; lipid; lipid emulsion; omega 3 fatty acid; adult; Article; cancer patient; cancer surgery; catheter infection; colorectal cancer; colostomy; controlled study; double blind procedure; drug efficacy; drug safety; female; human; hypoalbuminemia; immunomodulation; major clinical study; major surgery; male; prospective study; randomized controlled trial; stomach cancer; surgical infection; aged; blood; Colorectal Neoplasms; middle aged; postoperative care; procedures; Stomach Neoplasms; Glycine max; Aged; Colorectal Neoplasms; Double-Blind Method; Fat Emulsions, Intravenous; Fatty Acids, Omega-3; Female; Humans; Lipids; Male; Middle Aged; Postoperative Care; Prospective Studies; Stomach Neoplasms
Publisher
BioMed Central Ltd.
Type
journal article