Gastric CancerPhase 4NCT00558155
The Impact of Immunostimulating Nutrition on the Outcome of Surgery
A Phase 4 study testing peptisorb, Stresson and Parenteral nutrition in people with Gastric Cancer and Pancreatic Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Pancreatic Cancer
- What is being tested?
- peptisorb, Stresson and Parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2001to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- resectable gastric or pancreatic cancer
- age between 18 and 80 years,
- Karnofsky performance status score of 80 or more,
- adequate organ function
Who cannot join
- unresectable gastric or pancreatic cancer
- patients requiring preoperative nutritional support,
- disseminated tumors,
- serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5),
- renal or liver failure were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.
The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.
Read the detailed description
All patients qualified between June 2001 and December 2005 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients requiring preoperative nutritional support, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.
After completing tumor resection, patients who met the eligibility criteria were intraoperatively assigned to either of the treatment groups using sealed envelopes containing computer-generated allocation numbers. The following groups were generated: standard enteral nutrition (SEN), immunostimulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), and immunostimulating parenteral nutrition (IMPN). The study was carried out following the international ethical recommendations stated in the Declaration of Helsinki.
- Conditions
- Gastric Cancer, Pancreatic Cancer
- Being tested
- peptisorb, Stresson, Parenteral nutrition, Omegaven, Dipeptiven
- Keywords
- immunonutrition, enteral nutrition, parenteral nutrition, surgery
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peptisorbDrug
standard isocaloric eteral diet (1 ml = 1 kcal)
StressonDrug
Oligopeptic, enteral diet (1 ml=1.25 kcal)
Parenteral nutritionDrug
Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
Omegaven, DipeptivenDrug
Immunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
| Study group | Role | What they receive |
|---|---|---|
| SEN | Experimental | standard enteral nutrition Receives: Drug: peptisorb |
| IMEN | Experimental | immunostimulating enteral nutrition Receives: Drug: Stresson |
| SPN | Experimental | standard parenteral nutrition Receives: Drug: Parenteral nutrition |
| IMPN | Experimental | immunostimulating parenteral nutrition Receives: Drug: Omegaven, Dipeptiven |
What is being measured
The primary outcome is the main question the study is designed to answer.
During the postoperative period, all patients were observed for both surgical and non-surgical complications
Measured: 52 months
Secondary outcomes (1)
The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.
Measured: 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startJun 2001
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Investigators
- Stanislaw Klek, PhD, MD, Principal investigator, Jagiellonian University 1 Dept Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558155
- Sponsor's protocol ID
- 1st Dept Surg
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2007
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5.
PubMed 21820770Klek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1.
PubMed 18650630
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.
- ClinicalTrials.gov ID
- NCT00558155
- Acronym / sponsor ID
- 1st Dept Surg
- Conditions
- Gastric Cancer, Pancreatic Cancer
- Keywords
- immunonutrition, enteral nutrition, parenteral nutrition, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.
Detailed description
All patients qualified between June 2001 and December 2005 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients requiring preoperative nutritional support, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.
After completing tumor resection, patients who met the eligibility criteria were intraoperatively assigned to either of the treatment groups using sealed envelopes containing computer-generated allocation numbers. The following groups were generated: standard enteral nutrition (SEN), immunostimulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), and immunostimulating parenteral nutrition (IMPN). The study was carried out following the international ethical recommendations stated in the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SEN | Experimental | Drug: peptisorbstandard enteral nutrition |
| IMEN | Experimental | Drug: Stressonimmunostimulating enteral nutrition |
| SPN | Experimental | Drug: Parenteral nutritionstandard parenteral nutrition |
| IMPN | Experimental | Drug: Omegaven, Dipeptivenimmunostimulating parenteral nutrition |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- resectable gastric or pancreatic cancer
- age between 18 and 80 years,
- Karnofsky performance status score of 80 or more,
- adequate organ function
Key exclusion criteria (5 listed)
- unresectable gastric or pancreatic cancer
- patients requiring preoperative nutritional support,
- disseminated tumors,
- serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5),
- renal or liver failure were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peptisorbstandard isocaloric eteral diet (1 ml = 1 kcal) | Drug | SEN |
| StressonOligopeptic, enteral diet (1 ml=1.25 kcal) | Drug | IMEN |
| Parenteral nutritionProtein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel | Drug | SPN |
| Omegaven, DipeptivenImmunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel | Drug | IMPN |
Primary outcome
During the postoperative period, all patients were observed for both surgical and non-surgical complications
Time frame: 52 months
1 secondary outcome
The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.
Time frame: 52 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
- Derived from this study: PubMed 21820770Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5.
- Derived from this study: PubMed 18650630Klek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislaw Klek, PhD, MD principal investigator
Jagiellonian University 1 Dept Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peptisorb, Stresson and Parenteral nutrition in people with Gastric Cancer and Pancreatic Cancer, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
During the postoperative period, all patients were observed for both surgical and non-surgical complications (time frame: 52 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00558155, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2007.