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

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

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The baseline characteristics were comparable between the two groups: the median age was 68 years, approximately 60% of patients were male, and the mean BMI was around 22. There were no significant differences between the groups in ASA-PS, CCI score, oncologic features, surgical procedures or approaches, or the use of adjuvant chemotherapy.

Enrollment start date: May 15, 2023 Enrollment end date (last randomization): January 22, 2024 (January 29, 2024) End of follow-up: January 28, 2025

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The ONS group had significantly less body weight loss at 8 weeks postoperatively (-4.8% vs. -6.4%, P=0.039).There were no differences in handgrip strength, laboratory data, or adverse events between the groups. The mean ONS intake was 308.7 mL.

Patients undergoing curative gastrectomy for gastric cancer received a simple carbohydrate- and protein-based ONS for 8 weeks postoperatively. The primary endpoint, the percentage of body weight loss at 8 weeks after surgery, was significantly lower in the ONS group. Although handgrip strength and laboratory parameters did not differ between the groups for the secondary endpoints, some symptom scores were higher in the ONS group.

Nov. 07, 2025

Aug. 07, 2025

https://journals.lww.com/annalsofsurgery/abstract/9900/efficacy_of_simple_oral_nutritional_supplements.1421.aspx

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https://jrct.mhlw.go.jp/latest-detail/jRCTs051230012

Obama Kazutaka

Kyoto University Hospital

54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto

kobama@kuhp.kyoto-u.ac.jp

Ueno Kohei

Kyoto University Hospital

54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto

+81-75-366-7595

k_ueno@kuhp.kyoto-u.ac.jp

Complete

April. 13, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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

-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

Both

Gastric cancer

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

ONS, oral nutritional supplements

Stomach Neoplasms

The percentage of body weight loss from presurgical body weight to that at eight weeks after surgery

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

+81-75-753-4680

April. 10, 2023

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