Efficacy of oral nutritional supplements for the prevention of body weight loss after surgery to gatric cancer

Effects of the oral nutritional supplements (ONS) in postoperative patients with gastric cancer: a Multi-center, open-label parallel randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051230012

Enrollment

120

Registered

2023-04-13

Start date

2023-05-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

In addition to ordinary diet, take two packs (200kcal/200ml) nutirtional agent Isocal clear until eight weeks after surgery

ONS, oral nutritional supplements

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Aged 18 - 85 years 2)ECOG Performance Status (PS) 0-2 3)Oral intake will be possible postoperatively 4)Pathologically diagnosed epithelial malignancy of stomach (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, etc.) 5) cStage I-IVa OR CY1P0 6) Scheduled for radical gastrectomy (distal gastrectomy, pylorus preserving distal gastrectomy, proximal gastrectomy, total gastrectomy) 7) Esophageal invasion length is within 2 cm or no esophageal invasion 8) Written informed consent was obtained

Exclusion criteria

Exclusion criteria: -First exclusion criteria 1) Combined resection of liver, pancreas, colorectum( D1 or over) or/and periaortic lymph node 2) Remnant gastric cancer 3) Diagnosis of double cancer 4) Allergic to Isocalclear (e.g. milk allergy) 5) Have advanced renal dysfunction (eGFR < 30 mL/min/1.73m2) 6) Treated with insulin or poorly controlled diabetes mellitus. 7) Have organ dysfunction requiring strict restriction of drinking water. 8) Have psychiatric disorders or psychiatric symptoms that interfere with daily life 9) Others -Second exclusion criteria (postoperative criteria; POD5-7) 1) M1(no distant metastasis) or R2 resection (except for cy1) 2) Combined resection of liver, pancreas, or/and periaortic lymph node, esophagectomy 3) Unable to begin an oral diet 4) Gastrectomy was not performed 5) Allergic to Isocalclear (e.g. milk allergy) 6) Reefuse to participate in this study

Design outcomes

Primary

Measure	Time frame
The percentage of body weight loss from presurgical body weight to that at eight weeks after surgery	—

Secondary

Measure	Time frame
1) The percentage of body weight at 6 months and 12 months postoperatively 2) Nutritional blood test findings (hemoglobin, lymphocyte count, albumin) at 8 weeks, 6 months, and 12 months postoperatively 3) Intake adherence at 8 weeks postoperatively 4) Grip strength at 8 weeks, 6 months, and 12 months postoperatively 5) Nutrient intakes at 8 weeks postoperatively (FFQ) 6) Quality of life at 8 weeks, 6 months, and 12 months postoperatively (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L) 7) Adverse event	—

Measure

Time frame

1) The percentage of body weight at 6 months and 12 months postoperatively 2) Nutritional blood test findings (hemoglobin, lymphocyte count, albumin) at 8 weeks, 6 months, and 12 months postoperatively 3) Intake adherence at 8 weeks postoperatively 4) Grip strength at 8 weeks, 6 months, and 12 months postoperatively 5) Nutrient intakes at 8 weeks postoperatively (FFQ) 6) Quality of life at 8 weeks, 6 months, and 12 months postoperatively (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L) 7) Adverse event

—

Contacts

Public ContactKohei Ueno

Kyoto University Hospital

k_ueno@kuhp.kyoto-u.ac.jp+81-75-366-7595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026