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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Rate of post-operative complications

Outcome Time Frame:

On the day of discharge from hospital

Safety Issue:

No

Authority:

Switzerland: Swissmedic

Study ID:

SC-IRTD-01-05-CH

NCT ID:

NCT01023412

Start Date:

January 2006

Completion Date:

May 2008

Related Keywords:

  • Gastrointestinal Cancer
  • Immunonutrition
  • cancer
  • GI cancer surgery
  • Gastrointestinal Neoplasms

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