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

JRCT ID: jRCTs051230012

Registered date:13/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 15/05/2023
• Target sample size: 120
• Study type: Interventional
• Intervention(s): In addition to ordinary diet, take two packs (200kcal/200ml) nutirtional agent Isocal clear until eight weeks after surgery

Outcome(s)

• Primary Outcome: The percentage of body weight loss from presurgical body weight to that at eight weeks after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Obama Kazutaka
• Secondary Sponsor: Nishigori Tatsto
• Source(s) of Monetary Support: Nestle Japan