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- 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.
- Authors
Cheng-Jen Ma; Jin-Ming Wu; Hsiang-Lin Tsai; Ching-Wen Huang; Chien-Yu Lu; Li-Chu Sun; Ying-Ling Shih; Chao-Wen Chen; Jui-Fen Chuang; Ming-Hsun Wu; Ming-Yang Wang; Ming-Tsan Lin; Jaw-Yuan Wang
- 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. Trial registration: US ClinicalTrials.gov NCT00798447.
- Subjects
INTRAVENOUS fat emulsions; SOY oil; TRIGLYCERIDES; UNSATURATED fatty acids; COLON cancer; CLINICAL trials; ONCOLOGIC surgery
- Publication
Nutrition Journal, 2015, Vol 14, p1
- ISSN
1475-2891
- Publication type
Article
- DOI
10.1186/1475-2891-14-9