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

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, 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.

Figures

Figure 1
Figure 1
Diagram of randomization of patients with gastric or colorectal cancer to receive an n-3 fatty acid enriched parenteral lipid emulsion or a control parenteral lipid emulsion (MCT/LCT).
Figure 2
Figure 2
Distribution of mean (SD) during the study period. (a) IL-6, (b) CRP, (c) TNF-α, (d) PCT. *Follow up was defined as 30 days after last treatment.

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Source: PubMed

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