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

Gastrointestinal Cancer Clinical Trial

— IPOD-3  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01023412
• Other study ID #: SC-IRTD-01-05-CH
• Status: Terminated
• Phase: Phase 3
• First received: November 16, 2009
• Last updated: April 24, 2012
• Start date: January 2006
• Est. completion date: May 2008

Study information

• Verified date: April 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Lindenhof-Spital	Bern
Switzerland	Kantonsspital Liestal	Liestal
Switzerland	Kantonsspital Schaffausen	Schaffhausen
Switzerland	Kantonsspital St.Gallen	St.Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of post-operative complications		On the day of discharge from hospital	No
Secondary	Incidence of non-infectious complications		On the day of discharge from hospital	No
Secondary	Length of hospital stay		On the day of discharge from hospital	No
Secondary	Nutritional status evaluation		On the day of discharge from hospital	No
Secondary	Rate of post-operative infectious complications		On the day of discharge from hospital	No