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

Phase 3

Terminated

• Conditions: Gastrointestinal Cancer
• Interventions: Dietary Supplement: Immunonutrition

• Registration Number: NCT01023412
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Not specified
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional product	Immunonutrition	Oral nutritional supplement containing immuno nutrients
Isocaloric control	Immunonutrition	Isocaloric and isonitrogenous control without immuno nutrients

Primary Outcome Measures

Name	Time	Method
Rate of post-operative complications	On the day of discharge from hospital

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Lindenhof-Spital; 🇨🇭 Bern, Switzerland

Kantonsspital Liestal; 🇨🇭 Liestal, Switzerland

Kantonsspital Schaffausen; 🇨🇭 Schaffhausen, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St.Gallen, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Switzerland