1. Kanagawa Cancer Center, Department of Gastrointestinal Surgery, Yokohama, Japan.
2. Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
3. Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
4. Department of Biostatistics, School of Medicine, Yokohama City University, Yokohama, Japan
5. Aichi Cancer Center Hospital, Department of Gastroenterological Surgery, Nagoya, Japan
6. Osaka General Medical Center, Department of Surgery, Osaka, Japan
7. Division of Gastrointestinal Surgery, Chiba Cancer Center, Chiba, Japan
8. Saitama Cancer Center, Saitama, Japan
9. Department of Surgery, National Hospital Organization Osaka National Hospita, Osaka, Japan
10. Department of Upper Gastrointestinal Surgery Kitasato University School of Medicine, Sagamihara, Japan
*These two authors contributed equally.
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.
Keywords: gastric cancer, EPA, gastrectomy, lean body mass loss