Clinical trial NCT01023412: Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastrointestinal Cancer
Keywords: Immunonutrition
cancer
GI cancer surgery
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 107
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of post-operative complications
timeFrame: On the day of discharge from hospital
Secondary outcomes:
measure: Incidence of non-infectious complications
timeFrame: On the day of discharge from hospital
measure: Length of hospital stay
timeFrame: On the day of discharge from hospital
measure: Nutritional status evaluation
timeFrame: On the day of discharge from hospital
measure: Rate of post-operative infectious complications
timeFrame: On the day of discharge from hospital
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Bern
country: Switzerland
facility: Lindenhof-Spital
city: Liestal
country: Switzerland
facility: Kantonsspital Liestal
city: Schaffhausen
country: Switzerland
facility: Kantonsspital Schaffausen
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
References: