Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery (IPOD-3)

Effect of 3 Day Pre-operative Immunonutrition Regimen on Clinical Outcome in Well-nourished Patients With Gastrointestinal Cancer Undergoing Surgery , a Randomised Double-blind Controlled Trial

Major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management. Surgery-induced alterations of the immune system are well described and may play a role in the genesis of postoperative complications. It has been shown by several large scale clinical trials, that the use of immunonutrition in postoperative cancer surgery, trauma and critically ill patients resulted in an improved immunocompetence and/or reduced postoperatively infectious morbidity and/or length of hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this trial is to evaluate if a shorter administration of 3 days pre-operatively would be beneficial as well.

Study Overview

• Status: Terminated
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Dietary supplement: Immunonutrition

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
  • Baden, Switzerland, 5404
    • Kantonsspital Baden
  • Bern, Switzerland, 3012
    • Lindenhof-Spital
  • Liestal, Switzerland, 4410
    • Kantonsspital Liestal
  • Sankt Gallen, Switzerland, 9000
    • Kantonsspital St.Gallen
  • Schaffhausen, Switzerland, 8208
    • Kantonsspital Schaffausen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with GI cancer (stomach, pancreas, small and large bowel and rectum) histologically proven
• Well nourished patients as defined by a total score of <3 on the nutritional screening tool NRS-2002 (46) (Appendix III)
• Patients who are >= 18 years of age;
• Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study;
• Patients who have an ECOG performance status of 0, 1 or 2 (Appendix II).
• Patients able to orally consume 750 mL or more of liquid a day prior to surgery

Exclusion Criteria:

• Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
• Patients who are pregnant;
• Patients with cardiac failure as defined by the Goldman classification class>3
• Patients with respiratory failure (FEV<0.8l/sec)
• Patients with renal failure (Cr >= 3mg/dl or dialysis patients)
• Patients with hepatic dysfunction (Child >A)
• Patients suffering from an intestinal obstruction or ileum
• Patients with an Hb level of <=8 g/dL experiencing gastrointestinal hemorrhaging
• Patients with HIV, HCV, HBV
• Patients requiring immunosuppression treatments
• Patients undergoing emergency surgery
• Other patients determined by a study investigator to be inappropriate for enrolment in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutritional product; Oral nutritional supplement containing immuno nutrients	Dietary supplement: Immunonutrition; Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
Placebo Comparator: Isocaloric control; Isocaloric and isonitrogenous control without immuno nutrients	Dietary supplement: Immunonutrition; Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of post-operative complications	On the day of discharge from hospital

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of non-infectious complications	On the day of discharge from hospital
Length of hospital stay	On the day of discharge from hospital
Nutritional status evaluation	On the day of discharge from hospital
Rate of post-operative infectious complications	On the day of discharge from hospital

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: November 16, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimated): December 2, 2009

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cancer; Immunonutrition; GI cancer surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms; Gastrointestinal Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet; Immunonutrition Diet
• Other Study ID Numbers: SC-IRTD-01-05-CH