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A Phase III trial to evaluate the effect of perioperative nutrition enriched with eicosapentaenoic acid on body weight loss after total gastrectomy for T2-T4a gastric cancer.

Japanese journal of clinical oncology
May 1, 2012
Takaki Yoshikawa et al. (10 authors)
Clinical Trial, Phase IIIJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether perioperative nutrition enriched with eicosapentaenoic acid could prevent body weight loss after total gastrectomy for gastric cancer.

Results Summary

The abstract does not provide results, as it describes a planned Phase III trial rather than reporting outcomes.

Population

Patients undergoing total gastrectomy for gastric cancer.

Effective Dosage

Not specified (standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before and 21 days after surgery).

Duration

28 days total (7 pre-surgery, 21 post-surgery).

Interactions

None mentioned

Extracted Claims (8)
InterventionDirectionEndpointPopulationDosageImpactClaim #
perioperative nutrition enriched with eicosapentaenoic acid
decrease
body weight loss after total gastrectomy for gastric cancer
patients undergoing total gastrectomy for gastric cancer
-
prevent
#1
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
body weight loss at 1 and 3 months after surgery
patients undergoing total gastrectomy for gastric cancer
-
-
#2
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
relative performance of the supplement
patients undergoing total gastrectomy for gastric cancer
-
-
#3
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
loss of lean body mass at 1 and 3 months after surgery
patients undergoing total gastrectomy for gastric cancer
-
-
#4
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
lowest serum albumin level
patients undergoing total gastrectomy for gastric cancer
-
-
#5
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
quality of life
patients undergoing total gastrectomy for gastric cancer
-
-
#6
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
incidence of surgical morbidity and mortality
patients undergoing total gastrectomy for gastric cancer
-
-
#7
standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery
neutral
incidence of surgical site infection
patients undergoing total gastrectomy for gastric cancer
-
-
#8
Abstract

This randomized Phase III trial will evaluate whether perioperative nutrition enriched with eicosapentaenoic acid can prevent body weight loss after total gastrectomy for gastric cancer. The patients who enroll in this study will be randomly assigned to Group A: no supplementation with oral nutrients (standard diet) or Group B: standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery. For both groups, patients will undergo total gastrectomy with Roux-en Y reconstruction. The extent of dissection will principally follow the third edition of the Gastric Cancer Treatment Guideline published by the Japanese Gastric Cancer Association. When patients are diagnosed with pathological Stage II or III disease, adjuvant chemotherapy with S-1 will be initiated within 6 weeks after surgery and administered for 1 year. The primary endpoint will be the body weight loss at 1 and 3 months after surgery (double primary endpoints). The secondary endpoints will be the relative performance of the supplement, loss of lean body mass at 1 and 3 months after surgery, the lowest serum albumin level, quality of life, the incidence of surgical morbidity and mortality, and the incidence of surgical site infection.

Medical Subject Headings (MeSH)
AdultAgedAnastomosis, Roux-en-YAntimetabolites, AntineoplasticChemotherapy, AdjuvantDietary SupplementsDrug CombinationsEicosapentaenoic AcidFemaleGastrectomyHumansJapanMaleMiddle AgedNeoplasm StagingOxonic AcidPerioperative PeriodPractice Guidelines as TopicQuality of LifeResearch DesignStomach NeoplasmsTegafurTime FactorsTreatment OutcomeWeight Loss
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations10
Citations/Year0.8
Relative Citation Ratio0.36
NIH Percentile19.2%
Research Impact Scores
APT Score0.50
Weight Score1.41
Normalized Score0.57
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