gastric cancer
Conditions
Interventions
Participants in Group A (SED ONS implementation) will begin taking SED ONS one day prior to the scheduled hospital admission date. SED ONS provides 400 kcal per 100 ml per day. Nutritional counseling
Sponsors
Tokyo Metropolitan Tama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who underwent curative surgery for gastric cancer 2. Preoperative ECOG Performance Status: 0-2 3. Patients capable of oral intake 4. Patients capable of managing test meals and recording intake 5. Patients who have provided informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1.Patients with milk or gelatin allergies 2.Patients who required nutritional supplementation with ONS prior to surgery 3.Patients who underwent non-curative resection 4.Patients who required fasting for 28 days or longer due to postoperative complications 5.Patients with active concurrent cancer 6.Patients with diabetes who require insulin injections even after discharge 7.Patients undergoing hemodialysis 8.Other patients deemed inappropriate for study participation by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in weight at Day 84 (12 weeks after discharge) based on preoperative weight | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Body weight change rate at baseline (pre-surgery weight), before the start of the intervention, Day 28, Day 56, Day 182, and Day 365 2.Body weight change rate at Day 28, Day 56, Day 84, Day 182, and Day 365 relative to the weight before the start of the intervention 3.Change rate in daily food intake (5-point self-assessment compared to pre-surgery, recorded in a diary) 4.Nutritional supplement intake (nutritional supplement diary) 5.Daily food intake (energy intake) relative to preoperative levels at the start of the study, Day 28, Day 56, and Day 84 (temperature plate information at the start of the study, and nutritional guidance for other periods) 6.Quality of life assessment: PGSAS-37 (Postgastrectomy Syndrome Assessment Scale)8 before allocation, Day 84 7.Chemotherapy completion rate and adverse event assessment (only in cases where chemotherapy was administered) Day 84, Day 182, Day 365 8.Nutritional blood test values (total lymphocyte count, total protein, albumin, total cholesterol, prealbumin, cholinesterase) Pre-surgery, pre-randomization, Day 28, Day 56, Day 84, Day 182, Day 365 9.Body composition (impedance method) Changes in muscle mass, body fat mass, body fat percentage, skeletal muscle mass, and SMI from baseline (pre-surgery) to pre-randomization, Day 28, Day 56, Day 84, Day 182, and Day 365. However, measurements are not performed in patients with pacemakers. 10.Changes in grip strength and change rate Pre-surgery, Day 84 | — |
Countries
Japan
Contacts
Public ContactFumihiko Hatao
Tokyo Metropolitan Tama Medical Center Department of Surgery
Outcome results
None listed