Combined Oral and Parenteral Nutritional Therapy After Gastrectomy for Gastric Cancer

NCT07604857 | Completed

• 1 other identifier: XC17MCDI0065
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing gastrectomy for gastric cancer frequently experience insufficient oral intake during the postoperative recovery period because of reduced gastric capacity, early satiety, and gastrointestinal symptoms. Although oral nutritional supplements (ONS) are commonly recommended, adherence is often poor, resulting in a postoperative nutritional gap. This prospective randomized clinical trial was designed to evaluate the impact of combined oral and parenteral nutritional therapy on nutritional status and recovery after gastrectomy for gastric cancer. Patients were randomized to either a combined nutritional therapy group receiving oral nutritional supplementation plus parenteral nutrition or a control group receiving standard postoperative care. The primary endpoint was postoperative body weight change at 4 weeks after surgery. Secondary endpoints included body composition, nutritional intake, inflammatory and immune markers, laboratory parameters, and quality of life outcomes.

Conditions

Malnutitrion; Gastric Cancer (GC)

Keywords

Gastrectomy; Parenteral Nutrition; Oral Nutritional Supplement; Postoperative Recovery; Nutritional Support; Body Weight Loss; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Body Weight Change

  Difference between preoperative body weight and body weight measured at 4 weeks after gastrectomy for gastric cancer.

  4 weeks after surgery

Secondary Outcomes (1)

• Body Mass Index Change

  4 weeks after surgery

Study Arms (2)

Combined Nutritional Therapy

EXPERIMENTAL

Patients received combined oral nutritional supplementation and parenteral nutritional support during the postoperative recovery period after gastrectomy for gastric cancer.

Dietary Supplement: Oral Nutritional Supplementation; Other: Parenteral Nutrition

Standard Postoperative Care

ACTIVE COMPARATOR

Patients received standard postoperative nutritional management according to institutional clinical pathways after gastrectomy for gastric cancer.

Other: Standard Postoperative Nutritional Care

Interventions

Oral Nutritional Supplementation DIETARY_SUPPLEMENT

Patients received oral nutritional supplementation using Encover® three times daily during the postoperative recovery period after gastrectomy for gastric cancer.

Combined Nutritional Therapy

Parenteral Nutrition OTHER

Supplemental parenteral nutrition was administered during hospitalization and after discharge to support postoperative nutritional requirements.

Combined Nutritional Therapy

Standard Postoperative Nutritional Care OTHER

Standard postoperative nutritional management according to institutional clinical pathways, including routine postoperative diet advancement and conventional nutritional support.

Standard Postoperative Care

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 80 years
• Histologically confirmed gastric cancer
• Scheduled for curative total or subtotal gastrectomy
• Ability to tolerate oral intake
• Residence within areas covered by home care services
• Written informed consent

You may not qualify if:

• Body mass index (BMI) ≥30 kg/m² or \<18.5 kg/m²
• Uncontrolled diabetes mellitus
• Severe hepatic or renal dysfunction
• Active malignancy other than gastric cancer
• Previous chemotherapy or radiotherapy
• Allergy to oral nutritional supplement products

Sponsors & Collaborators

• Kyo Young Song: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Hyperphagia

Interventions

Dietary Supplements; Parenteral Nutrition

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the nutritional intervention, participants and investigators were not blinded to treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Surgery

Model Details: Participants were randomized in a 1:1 ratio to receive either combined oral and parenteral nutritional therapy or standard postoperative nutritional care after gastrectomy for gastric cancer.

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: October 1, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)