Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (G… (NCT01023412) | Clinical Trial Compass
TerminatedNot Applicable
Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery
Stopped: interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.
Switzerland107 participantsStarted 2006-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.