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

Phase 3

Recruiting

• Conditions: Gastric cancer; Stomach Neoplasms

• Registration Number: JPRN-jRCTs051230012
• Lead Sponsor: Obama Kazutaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified