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A Multicenter, Open-label, Randomized Controlled Trial to Evaluate the Effects of Customized Nutritional Formulations on Body Weight and Nutritional Status in Patients with Gastric Cancer Following Radical Gastrectomy

A Multicenter, Open-label, Randomized Controlled Trial to Evaluate the Effects of Customized Nutritional Formulations on Body Weight and Nutritional Status in Patients with Gastric Cancer Following Radical Gastrectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012045
Enrollment
244
Registered
2026-05-27
Start date
2025-12-19
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Dietary Supplement : “The intervention group consumed the customized nutritional formula together with the post-gastrectomy diet twice daily (1 pack per serving, 200 mL/pack), whereas the non-interven

Sponsors

Natural Way
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 65 years or older who were histologically diagnosed with primary gastric adenocarcinoma 2. Patients classified as Stage I, II, or III based on preoperative computed tomography (CT) and intraoperative tumor-node-metastasis (TNM) staging according to the American Joint Committee on Cancer(AJCC) 8th edition, who underwent proximal gastrectomy with double tract reconstruction or total gastrectomy 3. Patients capable of oral intake after gastrectomy 4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 5. Individuals who voluntarily provided written informed consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: 1. Patients who received preoperative neoadjuvant chemotherapy 2. Patients who developed postoperative complications of Clavien–Dindo classification grade III or higher prior to discharge 3. Patients with a history of cancer in another organ within the past 5 years, or those with a concurrent malignancy in another organ 4. Patients with a history of gastric resection surgery; however, those who have undergone endoscopic submucosal dissection (ESD) were included 5. Patients diagnosed with diabetes or currently receiving antidiabetic medication 6. Patients with chronic inflammatory diseases(Chronic obstructive pulmonary disease [COPD], chronic hepatitis, Chronic kidney disease [CKD], inflammatory bowel disease [IBD], Chron`s disease [CD], chronic pancreatitis) 7. Patients with severe comorbidities such as pulmonary or cardiac disease, or those with uncontrolled active infections 8. Patients who had consistently taken oral nutritional supplementation products for at least 4 weeks prior to surgery 9. Any other cases deemed unsuitable for the study at the discretion of the principal investigator

Design outcomes

Primary

MeasureTime frame
Weight

Secondary

MeasureTime frame
Skeletal muscle mass and body fat mass;KOrean QUality of life in Stomach cancer patients Study group questionnaire–40(KOQUSS-40) score;European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module(EORTC QLQ-STO22) score

Countries

Korea, Republic of

Contacts

Public ContactHyoung Il Kim

Yonsei University Health System, Severance Hospital

cairus@yuhs.ac+82-2-2228-2095

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 11, 2026