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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Dietary Supplement: Immunonutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunonutrition, cancer, GI cancer surgery