An interventional study of Oral Nutritional Supplementation (ONS) and Structured Dietary Counseling and Standard Perioperative Care in Gastric Cancer (GC), sponsored by Hanoi Medical University. Completed at 1 site in Vietnam. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Hanoi Medical University · Not applicable, Interventional, and Supportive care
This prospective, 1:1 group-matched non-randomized controlled trial evaluates the impact of a structured perioperative nutritional intervention on functional gastrointestinal recovery, post-operative length of hospital stay, anthropometries status, paraclinical test, and multidimensional nutritional-immunological status in gastric cancer patients undergoing elective radical total gastrectomy.
Total gastrectomy induces severe surgical stress, catabolic malnutrition, and rapid loss of body weight and muscle mass, which severely compromises post-operative immune function and clinical recovery. Standard perioperative care often lacks structured, post-discharge immunonutrient supplementation, leaving patients at high risk for prolonged catabolic depletion.
In this study, eligible post-total gastrectomy gastric cancer patients were allocated via 1:1 group matching based on age, sex, AJCC tumor stage, and baseline malnutrition status (GLIM criteria) into two arms (n = 38 per arm):
Primary outcome measures include gastrointestinal recovery metrics (time to first flatus and time to oral feeding initiation) and postoperative length of hospital stay. Secondary outcomes comprise multidimensional nutritional-immunological assessments at baseline (T0) and 1 month postoperatively (T1), evaluated by GLIM criteria, Prognostic Nutritional Index (PNI), Controlling Nutritional Status (CONUT) score, body composition, serum albumin, protein levels, anemia, and 30-day postoperative complication rates.
Randomization, Patient Allocation, and Matching A total of 143 adult patients with histologically confirmed gastric cancer indicated for total gastrectomy at Vietnam National Cancer Hospital (Tan Trieu campus) were enrolled. Patients were allocated in a 1:1 ratio into an Intervention Group (n = 38) and a Control Group (n = 38). To minimize allocation bias, patient matching was conducted based on four baseline stratification criteria: Gender: Male, Female, Age Group: 18-40 years, 41-59 years, ≥60 years, Tumor Stage: Stage I, II, III, or IV.
Baseline Malnutrition Status: Diagnosed according to the Global Leadership Initiative on Malnutrition (GLIM) criteria (No Malnutrition, Moderate Malnutrition, Severe Malnutrition).
Detailed Intervention Protocols
Intervention Arm (Active Medical Nutrition Protocol, n = 38):
Postoperative Days 1-4 (Parenteral Support): Patients received total parenteral nutrition (TPN) providing a target energy intake of 25 kcal/kg/day and a protein intake of 1.0 g/kg/day, comprising balanced parenteral glucose, amino acids, lipid emulsions, essential vitamins, and electrolytes.
Early Enteral Feeding (Within 24-48 Hours): Enteral nutrition was initiated early (within 24-48 hours postoperatively, prior to the return of bowel flatus) via nasogastric tube (NGT) continuous micro-drip feeding (initial rate: 10 drops/min or 0.5 mL/min, 100 mL per feed) or direct oral intake as tolerated. Tolerance was monitored every 4 hours; feeding proceeded if Gastric Residual Volume (GRV) was \<250 mL.
Specialized Immunonutrition Formula: Enteral feeds comprised a specialized peptide-hydrolyzed formula combining animal and plant proteins, supplemented with eicosapentaenoic acid (EPA/Omega-3 fatty acids) and specific immunonutrients (L-Arginine 3.5 g/250 mL, L-Glutamine 2.5 g/250 mL, and RNA Nucleotides 1.4 g/250 mL). Each 250 mL package provided 300 kcal, 16.5 g protein, 7.8 g fat, and 41.0 g carbohydrates.
Post-Discharge Nutritional Care (Up to 1 Month): Postoperative nutritional intake targets were maintained at ≥30 kcal/kg/day and ≥1.0 g protein/kg/day divided into 6-8 small meals daily. Patients received weekly structured telephone nutritional counseling and recorded 24-hour dietary intake logs.
Control Arm (Standard Hospital Care, n = 38):
Postoperative Days 1-2: Received standard intravenous fluid rehydration (0.9% NaCl, 5% Dextrose) and partial parenteral nutrition.
Post-Flatus Feeding: Enteral feeding was strictly withheld until the clinical return of bowel flatus. Once flatus returned, oral feeding was initiated sequentially with thin rice water, progressing to soft rice porridge and standard hospital post-surgical diets, without structured immunonutrition supplements or defined individual caloric targets.
Data collection and clinical evaluations were conducted at two main protocol timepoints: Baseline (T0, Preoperative) and 1-Month Postoperative Follow-Up (T1):
Anthropometrics \& Body Composition:
Weight, Height, and BMI: Measured using standardized digital scales and stadiometers.
Body Composition Analysis: Bioelectrical Impedance Analysis (BIA, Tanita device) was used to measure total body fat percentage and skeletal muscle mass (kg).
Muscle Strength and Reserve: Handgrip strength (HGS, kg) measured via dynamometer and Mid-Upper Arm Circumference (MUAC, cm).
Biochemical and Hematological Parameters:
Venous blood samples drawn at baseline and follow-up to analyze serum Albumin (g/L), Total Protein (g/L), Hemoglobin (g/L), Total Lymphocyte Count (TLC, cells/mm³), lipid profiles, and liver/renal function markers.
Gastrointestinal and Clinical Outcomes:
Functional Recovery: Exact time (hours) to first bowel sound, first flatus, and first oral feeding.
Complications \& Hospital Length of Stay: Monitoring for post-surgical GI side effects (nausea, vomiting, diarrhea, early satiety, dumping symptoms), infectious complications, and total postoperative hospital stay duration (days)
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 84 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a structured perioperative nutritional care pathway comprising individualized dietary counseling, disease-specific texture-modified diets, and oral nutritional supplementation (ONS; Orgalife, 250 mL/serving, 1 servings providing 300 kcal and 16.5 g protein enriched with L-arginine, L-glutamine, and omega-3) for 30 consecutive days.
Dietary Supplement: Oral Nutritional Supplementation (ONS) and Structured Dietary Counseling
Participants receive standard perioperative surgical care and routine hospital or family-prepared soft diets without structured oral immunonutrition or specialized perioperative dietary counseling.
Other: Standard Perioperative Care
Participants receive a structured perioperative nutritional care pathway comprising individualized dietary counseling and oral nutritional supplementation (ONS; Orgalife). Patients consume 2 or more servings (250 mL/serving) per day of a specialized hydrolyzed peptide-based formula for 30 consecutive days (starting after surgery 24-48h). A serving provides 300 kcal and 16.5 g protein, enriched with bioactive immunonutrients (1.75 g L-arginine, 1.5 g L-glutamine, 1.4g nucleic acids, and 1.5 g omega-3 fatty acids). The intervention is delivered alongside individualized texture-modified small-frequent meal plans post-gastrectomy.
Participants receive standard perioperative surgical care, routine dietary advice, and hospital or family-prepared soft diets without structured oral immunonutrition or specialized perioperative dietary counseling.
Also known as: standard perioperative surgical care, routine dietary advice
Body Weight
Participant body weight measured in kilograms (kg) under fasting conditions using a calibrated body composition balance.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Body Mass Index (BMI)
Calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Skeletal Muscle Mass
Total skeletal muscle mass measured in kilograms (kg) using multi-frequency bioelectrical impedance analysis (BIA; Tanita body composition analyzer).
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Handgrip Muscle Strength
Upper-body muscle strength measured in kilograms (kg) using a calibrated digital hand dynamometer.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Time to First Flatus
Time elapsed from surgical wound closure to the first recorded passage of flatus (bowel movement), measured in hours as a clinical indicator of gastrointestinal motility restoration.
Time frame: From surgical completion up to 14 days postoperatively (during inpatient stay)
Time to Oral Feeding Initiation
Time elapsed from completion of surgery to the first successful and tolerated resumption of oral clear liquid feeding, recorded in hours.
Time frame: From surgical completion up to 14 days postoperatively (during inpatient stay)
Postoperative Length of Hospital Stay
Total duration of hospitalization, calculated as the number of days elapsed from surgery to hospital discharge.
Time frame: From day of surgery up to discharge (up to 30 days)
Postoperative Complication Rate
Incidence of surgical and medical post-operative complications (e.g., anastomotic leak, wound infection, pneumonia) recorded within 30 days following total gastrectomy.
Time frame: Up to 30 days postoperatively
Mid-Upper Arm Circumference (MUAC)
Anthropometric indicator of arm skeletal muscle and subcutaneous fat reserves measured in centimeters (cm) using a non-stretch tape.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Body Fat Percentage
Proportion of total body mass composed of adipose tissue (%), measured via multi-frequency bioelectrical impedance analysis (BIA).
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Postoperative Malnutrition Rate Evaluated by GLIM Criteria
Proportion of participants diagnosed with malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) consensus framework, combining phenotypic (weight loss, low BMI) and etiologic criteria (reduced food intake, systemic inflammation).
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Prognostic Nutritional Index (PNI) Score and Abnormal PNI Rate
PNI score calculated as: Serum Albumin (g/L) + 5 × Total Lymphocyte Count (10⁹/L). Abnormal PNI rate is defined as the proportion of participants with PNI \< 45.0.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Controlling Nutritional Status (CONUT) Score and High-Risk Rate
Derived from serum albumin (g/dL), total cholesterol (mg/dL), and total lymphocyte count (/mm³), ranging from 0 to 12. High-risk CONUT rate is defined as the proportion of participants with a score ≥ 5.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Serum Albumin Concentration
Circulating serum albumin level measured in grams per liter (g/L) or grams per deciliter (g/dL) as a biomarker of visceral protein reserves.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Serum Total Protein Concentration
Total circulating serum protein level measured in grams per liter (g/L) from venous blood samples.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Total Lymphocyte Count (TLC)
Absolute peripheral blood lymphocyte count (10⁹/L or cells/mm³) obtained from complete blood count (CBC) to reflect cellular immune status.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Blood Hemoglobin Concentration
irculating blood hemoglobin level measured in grams per deciliter (g/dL) as a measure of anemia and red blood cell capacity.
Time frame: Baseline (pre-operative, T0) and 1 month post-surgery (T1)
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article (including baseline demographics, clinical recovery metrics, anthropometrics, GLIM, CONUT, PNI scores, and relevant blood laboratory parameters) will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available starting 6 months following publication of the final study results and will remain accessible for up to 3 years.
Access criteria: Data will be shared with qualified academic researchers upon approval of a formal research proposal to achieve the approved aims and completion of a data transfer agreement. Requests should be directed to the corresponding author at dr.peace2801@gmail.com.
Ran from Apr 2023 to primary completion in Apr 2024, 12 months.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's 12 months is below that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Hanoi Medical University