NCT01023412

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

November 16, 2009

Last Update Submit

December 3, 2025

Conditions

Gastrointestinal Cancer

Keywords

ImmunonutritioncancerGI cancer surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of post-operative complications

    On the day of discharge from hospital

Secondary Outcomes (4)

  • Incidence of non-infectious complications

    On the day of discharge from hospital

  • Length of hospital stay

    On the day of discharge from hospital

  • Nutritional status evaluation

    On the day of discharge from hospital

  • Rate of post-operative infectious complications

    On the day of discharge from hospital

Study Arms (2)

Nutritional product

ACTIVE COMPARATOR

Oral nutritional supplement containing immuno nutrients

Dietary Supplement: Immunonutrition

Isocaloric control

PLACEBO COMPARATOR

Isocaloric and isonitrogenous control without immuno nutrients

Dietary Supplement: Immunonutrition

Interventions

ImmunonutritionDIETARY_SUPPLEMENT

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

Isocaloric controlNutritional product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Lindenhof-Spital

Bern, 3012, Switzerland

Location

Kantonsspital Liestal

Liestal, 4410, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, 9000, Switzerland

Location

Kantonsspital Schaffausen

Schaffhausen, 8208, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsNeoplasms

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

December 2, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations

CH(6)