Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery (IPOD-3)
This study has been terminated.
(interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.)
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01023412
First received: November 16, 2009
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Cancer |
Dietary Supplement: Immunonutrition |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- Rate of post-operative complications [ Time Frame: On the day of discharge from hospital ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of non-infectious complications [ Time Frame: On the day of discharge from hospital ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: On the day of discharge from hospital ] [ Designated as safety issue: No ]
- Nutritional status evaluation [ Time Frame: On the day of discharge from hospital ] [ Designated as safety issue: No ]
- Rate of post-operative infectious complications [ Time Frame: On the day of discharge from hospital ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | January 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nutritional product
Oral nutritional supplement containing immuno nutrients
|
Dietary Supplement: Immunonutrition
Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
|
|
Placebo Comparator: Isocaloric control
Isocaloric and isonitrogenous control without immuno nutrients
|
Dietary Supplement: Immunonutrition
Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023412
Locations
| Switzerland | |
| Kantonsspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Kantonsspital Baden | |
| Baden, Switzerland, 5404 | |
| Lindenhof-Spital | |
| Bern, Switzerland, 3012 | |
| Kantonsspital Liestal | |
| Liestal, Switzerland, 4410 | |
| Kantonsspital Schaffausen | |
| Schaffhausen, Switzerland, 8208 | |
| Kantonsspital St.Gallen | |
| St.Gallen, Switzerland, 9000 | |
Sponsors and Collaborators
Nestlé
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01023412 History of Changes |
| Other Study ID Numbers: | SC-IRTD-01-05-CH |
| Study First Received: | November 16, 2009 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Nestlé:
|
Immunonutrition cancer GI cancer surgery |
Additional relevant MeSH terms:
|
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013