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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01023412

Acronym

IPOD-3

Enrollment

107

Registered

2009-12-02

Start date

2006-01-31

Completion date

2008-05-31

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer

Keywords

Immunonutrition, cancer, GI cancer surgery

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTImmunonutrition

Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026