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

NCT ID: NCT01023412

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-05-31

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nutritional product

Oral nutritional supplement containing immuno nutrients

Group Type: ACTIVE_COMPARATOR

Immunonutrition

Intervention Type: DIETARY_SUPPLEMENT

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

Isocaloric control

Isocaloric and isonitrogenous control without immuno nutrients

Group Type: PLACEBO_COMPARATOR

Immunonutrition

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Immunonutrition

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kantonsspital Aarau

Aarau, , Switzerland

Kantonsspital Baden

Baden, , Switzerland

Lindenhof-Spital

Bern, , Switzerland

Kantonsspital Liestal

Liestal, , Switzerland

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Kantonsspital Schaffausen

Schaffhausen, , Switzerland

Countries

Switzerland

Other Identifiers

SC-IRTD-01-05-CH

Identifier Type: -

Identifier Source: org_study_id