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

Nestlé

Status

Terminated

Conditions

Gastrointestinal Cancer

Treatments

Dietary Supplement: Immunonutrition

Study type

Interventional

Funder types

Industry

Identifiers

NCT01023412

SC-IRTD-01-05-CH

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No 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