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Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer
Background: In previous our phase III study to compare perioperative standard diet with or without Eicosapentaenoic acid (EPA)-enriched oral nutritional supplement (EPA-ON), additional EPA-ON did not contribute to prevent body weight loss after total gastrectomy. This report clarified whether EPA-ON...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Ivyspring International Publisher
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6400678/ https://www.ncbi.nlm.nih.gov/pubmed/30854113 http://dx.doi.org/10.7150/jca.29632 |
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author | Aoyama, Toru Yoshikawa, Takaki Ida, Satoshi Cho, Haruhiko Sakamaki, Kentaro Ito, Yuichi Fujitani, Kazumasa Takiguchi, Nobuhiro Kawashima, Yoshiyuki Nishikawa, Kazuhiro Oshima, Takashi Nunobe, Souya Hiki, Naoki |
author_facet | Aoyama, Toru Yoshikawa, Takaki Ida, Satoshi Cho, Haruhiko Sakamaki, Kentaro Ito, Yuichi Fujitani, Kazumasa Takiguchi, Nobuhiro Kawashima, Yoshiyuki Nishikawa, Kazuhiro Oshima, Takashi Nunobe, Souya Hiki, Naoki |
author_sort | Aoyama, Toru |
collection | PubMed |
description | Background: In previous our phase III study to compare perioperative standard diet with or without Eicosapentaenoic acid (EPA)-enriched oral nutritional supplement (EPA-ON), additional EPA-ON did not contribute to prevent body weight loss after total gastrectomy. This report clarified whether EPA-ON could prevent loss of lean body mass (LBM) after total gastrectomy, a key secondary endpoint, in our phase III trial. Methods: This phase III study was designed as multicenter, open-label, superiority, randomized trial to confirm the preventive effect of EPA-ON body weight loss after total gastrectomy for gastric cancer. Eligible patients were randomized to either Standard-diet group or EPA-ON group by a centralized dynamic method. Standard-diet group was given no additional nutritional supplementation perioperatively (standard diet), while EPA-ON group was given an EPA-enriched supplement (ProSure(®), Abbott Japan, Tokyo, Japan) in addition to their standard diet. This supplement included 600 kcal with 2.2 g/day of EPA. For both groups, patients underwent total gastrectomy with Roux-en Y reconstruction. Results: A total of 123 patients (Group A: 60, Group B: 63) were analyzed in the study. All background factors were well balanced between the both groups. Median loss of LBM was 6.74% (range -3.91% to 20.27%) in the Standard-diet group and 6.89% (range -5.11% to 20.04%) in the EPA-ON group at 1 month after surgery and was 8.59% (range -4.40% to 20.27%) in the Standard-diet group and 7.77% (range -5.57% to 23.35%) in the EPA-ON group at 3 months after surgery, which was not significantly different at the both (p=0.794 and p=0.393, respectively). Conclusions: The perioperative EPA-ON could not be recommended to prevent loss of LBM after total gastrectomy. |
format | Online Article Text |
id | pubmed-6400678 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Ivyspring International Publisher |
record_format | MEDLINE/PubMed |
spelling | pubmed-64006782019-03-08 Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer Aoyama, Toru Yoshikawa, Takaki Ida, Satoshi Cho, Haruhiko Sakamaki, Kentaro Ito, Yuichi Fujitani, Kazumasa Takiguchi, Nobuhiro Kawashima, Yoshiyuki Nishikawa, Kazuhiro Oshima, Takashi Nunobe, Souya Hiki, Naoki J Cancer Research Paper Background: In previous our phase III study to compare perioperative standard diet with or without Eicosapentaenoic acid (EPA)-enriched oral nutritional supplement (EPA-ON), additional EPA-ON did not contribute to prevent body weight loss after total gastrectomy. This report clarified whether EPA-ON could prevent loss of lean body mass (LBM) after total gastrectomy, a key secondary endpoint, in our phase III trial. Methods: This phase III study was designed as multicenter, open-label, superiority, randomized trial to confirm the preventive effect of EPA-ON body weight loss after total gastrectomy for gastric cancer. Eligible patients were randomized to either Standard-diet group or EPA-ON group by a centralized dynamic method. Standard-diet group was given no additional nutritional supplementation perioperatively (standard diet), while EPA-ON group was given an EPA-enriched supplement (ProSure(®), Abbott Japan, Tokyo, Japan) in addition to their standard diet. This supplement included 600 kcal with 2.2 g/day of EPA. For both groups, patients underwent total gastrectomy with Roux-en Y reconstruction. Results: A total of 123 patients (Group A: 60, Group B: 63) were analyzed in the study. All background factors were well balanced between the both groups. Median loss of LBM was 6.74% (range -3.91% to 20.27%) in the Standard-diet group and 6.89% (range -5.11% to 20.04%) in the EPA-ON group at 1 month after surgery and was 8.59% (range -4.40% to 20.27%) in the Standard-diet group and 7.77% (range -5.57% to 23.35%) in the EPA-ON group at 3 months after surgery, which was not significantly different at the both (p=0.794 and p=0.393, respectively). Conclusions: The perioperative EPA-ON could not be recommended to prevent loss of LBM after total gastrectomy. Ivyspring International Publisher 2019-01-29 /pmc/articles/PMC6400678/ /pubmed/30854113 http://dx.doi.org/10.7150/jca.29632 Text en © Ivyspring International Publisher This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) license (https://creativecommons.org/licenses/by-nc/4.0/). See http://ivyspring.com/terms for full terms and conditions. |
spellingShingle | Research Paper Aoyama, Toru Yoshikawa, Takaki Ida, Satoshi Cho, Haruhiko Sakamaki, Kentaro Ito, Yuichi Fujitani, Kazumasa Takiguchi, Nobuhiro Kawashima, Yoshiyuki Nishikawa, Kazuhiro Oshima, Takashi Nunobe, Souya Hiki, Naoki Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
title | Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
title_full | Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
title_fullStr | Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
title_full_unstemmed | Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
title_short | Effects of perioperative Eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
title_sort | effects of perioperative eicosapentaenoic acid-enriched oral nutritional supplement on lean body mass after total gastrectomy for gastric cancer |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6400678/ https://www.ncbi.nlm.nih.gov/pubmed/30854113 http://dx.doi.org/10.7150/jca.29632 |
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