Clinical trial · Interventional
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
NCT03123432CI-TRIAL-00027116completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunomodulating nutrients enriched diet | Dietary Supplement | — | UNRESOLVED |
| standard diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- immunomodulating nutrients enriched diet
- description
- Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.
- interventionNames
- Dietary Supplement: immunomodulating nutrients enriched diet
- type
- ACTIVE_COMPARATOR
- label
- standard diet
- description
- Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 20-85 years old * Histologically proven primary gastric cancer or GIST. * Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc. * Patient is able to understand the requirements of the study and written informed consent was obtained from each subject. Exclusion Criteria: * They were less than 20 years or over 85 years old * Hepatic dysfunction or bile stasis (serum total bilirubin \>2.5 mg/dL) * Renal dysfunction (serum creatinine \>1.5 mg/dL), or required hemodialysis * Cardiac dysfunction (NYHA functional class \>III, or stroke history) * Severe hypoalbuminemia (albumin \<2.5 g/dL) * Karnofsky performance status less than 60 * Overweight (body mass index \[BMI\] \>30 kg/m2) * Exhibited drug abuse or chronic alcoholism * Had life-threatening disease, or underwent emergent surgery * With infection or bowel obstruction * Pregnant or lactating * Had received chemotherapy within 14 days of the initiation of the trial * Had received immunosuppressive therapy or had immunological diseases recently * Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study * Hypersensitive to casein, fish oil, soybean, or corn oil
References
Publications (0)
Data not yet available
No reference posted for this study.