Postoperative Enteral Immunonutrition in Gastric Cancer

Jagiellonian University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Dietary Supplement: Standard nutrition (Peptisorb); Dietary Supplement: Immunomodulating nutrition (Reconvan)

Study type: Interventional

Funder types: Other

Identifiers

NCT02647476

KBET/91/L/2004

Details and patient eligibility

About

Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.

The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.

The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Full description

Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.

Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.

The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.

The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gastric cancer confirmed in histopathological examination
• elective operation due to gastric cancer
• informed consent signed
• age > 18 years
• normal nutritional status or mild to moderate malnutrition

Exclusion criteria

• severe malnutrition which required parenteral nutrition
• urgent operation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Study group

Experimental group

Description:

Immunomodulating nutrition (Reconvan)

Treatment:

Dietary Supplement: Immunomodulating nutrition (Reconvan)

Control group

Active Comparator group

Description:

Standard nutrition (Peptisorb)

Treatment:

Dietary Supplement: Standard nutrition (Peptisorb)