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

Primary Purpose

Gastrointestinal Cancer

Status

Terminated

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Immunonutrition

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring Immunonutrition, cancer, GI cancer surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Does not accept 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

Sites / Locations

Kantonsspital Aarau
Kantonsspital Baden
Lindenhof-Spital
Kantonsspital Liestal
Kantonsspital Schaffausen
Kantonsspital St.Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nutritional product

Isocaloric control

Arm Description

Oral nutritional supplement containing immuno nutrients

Isocaloric and isonitrogenous control without immuno nutrients

Outcomes

Primary Outcome Measures

Rate of post-operative complications

Secondary Outcome Measures

Incidence of non-infectious complications

Length of hospital stay

Nutritional status evaluation

Rate of post-operative infectious complications

Full Information

NCT ID

NCT01023412

First Posted

November 16, 2009

Last Updated

April 24, 2012

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT01023412

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

January 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Cancer

Keywords

Immunonutrition, cancer, GI cancer surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutritional product

Arm Type

Active Comparator

Arm Description

Oral nutritional supplement containing immuno nutrients

Arm Title

Isocaloric control

Arm Type

Placebo Comparator

Arm Description

Isocaloric and isonitrogenous control without immuno nutrients

Intervention Type

Dietary Supplement

Intervention Name(s)

Immunonutrition

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of post-operative complications

Time Frame