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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023412
Recruitment Status : Terminated (interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.)
First Posted : December 2, 2009
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Dietary Supplement: Immunonutrition Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Rate of post-operative complications [ Time Frame: On the day of discharge from hospital ]

Secondary Outcome Measures :
  1. Incidence of non-infectious complications [ Time Frame: On the day of discharge from hospital ]
  2. Length of hospital stay [ Time Frame: On the day of discharge from hospital ]
  3. Nutritional status evaluation [ Time Frame: On the day of discharge from hospital ]
  4. Rate of post-operative infectious complications [ Time Frame: On the day of discharge from hospital ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023412


Locations
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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

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01023412     History of Changes
Other Study ID Numbers: SC-IRTD-01-05-CH
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Nestlé:
Immunonutrition
cancer
GI cancer surgery

Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases