TerminatedNot Applicable

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

Stopped: interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.

Switzerland107 participantsStarted 2006-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of post-operative complications

Timeframe: On the day of discharge from hospital

Trial details

NCT IDNCT01023412

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05