Clinical trial · Interventional
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrectomy | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary education(nutritional counselling) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- SE-STG
- description
- simplified dietary education arm in subtotal gastrectomy group.
- interventionNames
- Other: Dietary education(nutritional counselling)
- type
- ACTIVE_COMPARATOR
- label
- IE-STG
- description
- intensive dietary education arm in subtotal gastrectomy group
- interventionNames
- Other: Dietary education(nutritional counselling)
- type
- ACTIVE_COMPARATOR
- label
- SE-TG
- description
- simplified dietary education arm in total gastrectomy group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven primary gastric adenocarcinoma, * T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging * location of primary tumor; antrum, or angle, , lower body or mid body of the stomach * No evidence of other distant metastasis, * age ≥ 20 year old, ≤ 75 year old * no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies * adequate organ functions defined as indicated below: 1. WBC count: 3000/mm3 \~12,000/mm3, 2. \> serum Hemoglobin 8.0 g/dL 3. \> serum Platelet 100 000/mm3, 4. \< serum AST 100 IU/L, 5. \<serum ALT 100 IU/L, 6. \< Total Bilirubin 2.0 mg/dL, * written signed informed consent Exclusion Criteria: * active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer), * gastric remnant cancer * ≥T3, T4 in surgical staging before resection * N2 or more (number of metastatic lymph nodes ≥3) in CT scan * histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others * pregnant or breast-feeding women, * mental disorder(diagnosed with mental disorder on medical record), * unstable angina or myocardial infarction within 6 months of the trial, * unstable hypertension, * diabetes mellitus on insulin, * severe respiratory disease requiring continuous oxygen therapy, * previous upper abdominal surgery except laparoscopic cholecystectomy, * surgical complication
References
Publications (1)
- DERIVEDLee AR, Bae JM, Choi MG, An JY, Kim EM, Park B. Nutritional Counseling for Patients With Gastric Cancer After Subtotal Gastrectomy: A Randomized Clinical Trial. J Gastric Cancer. 2025 Oct;25(4):593-604. doi: 10.5230/jgc.2025.25.e43. PMID 41093778