Gastric CancerPhase 3NCT02647476
Postoperative Enteral Immunonutrition in Gastric Cancer
A Phase 3 study testing Immunomodulating nutrition (Reconvan) and Standard nutrition (Peptisorb) in people with Gastric Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Immunomodulating nutrition (Reconvan) and Standard nutrition (Peptisorb)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2004to Oct 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric cancer confirmed in histopathological examination
- elective operation due to gastric cancer
- informed consent signed
- age > 18 years
- normal nutritional status or mild to moderate malnutrition
Who cannot join
- severe malnutrition which required parenteral nutrition
- urgent operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
Read the detailed description
Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
- Conditions
- Gastric Cancer
- Being tested
- Immunomodulating nutrition (Reconvan), Standard nutrition (Peptisorb)
- Keywords
- immunonutrition, gastric cancer, enteral nutrition
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunomodulating nutrition (Reconvan)Dietary supplement
protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
Standard nutrition (Peptisorb)Dietary supplement
oligopeptide, low-fat, isocaloric, non-residue diet
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Immunomodulating nutrition (Reconvan) Receives: Dietary Supplement: Immunomodulating nutrition (Reconvan) |
| Control group | Active comparator | Standard nutrition (Peptisorb) Receives: Dietary Supplement: Standard nutrition (Peptisorb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate
Complication rate during 30 days after the operation
Measured: 30 days
Secondary outcomes (1)
Overall survival
5-year overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startNov 2004
- Primary completionDec 2010
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Pach, MD, Ph D, Jagiellonian University
- Investigators
- Radosław Pach, MD PhD, Study chair, 1st Dept. of General Surgery, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647476
- Sponsor's protocol ID
- KBET/91/L/2004
- Status last verified
- Feb 2019
- First submitted
- 1 Jan 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Scislo L, Pach R, Nowak A, Walewska E, Gadek M, Brandt P, Puto G, Szczepanik AM, Kulig J. The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients - Randomized Clinical Trial. Nutr Cancer. 2018 Apr;70(3):453-459. doi: 10.1080/01635581.2018.1445770. Epub 2018 Mar 13.
PubMed 29533110
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT02647476
- Acronym / sponsor ID
- KBET/91/L/2004
- Conditions
- Gastric Cancer
- Keywords
- immunonutrition, gastric cancer, enteral nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Jan 2016 (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.
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
Detailed description
Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.
Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Dietary Supplement: Immunomodulating nutrition (Reconvan)Immunomodulating nutrition (Reconvan) |
| Control group | Active comparator | Dietary Supplement: Standard nutrition (Peptisorb)Standard nutrition (Peptisorb) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- gastric cancer confirmed in histopathological examination
- elective operation due to gastric cancer
- informed consent signed
- age > 18 years
- normal nutritional status or mild to moderate malnutrition
Key exclusion criteria (2 listed)
- severe malnutrition which required parenteral nutrition
- urgent operation
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 |
|---|---|---|
| Immunomodulating nutrition (Reconvan)protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi | Dietary supplement | Study group |
| Standard nutrition (Peptisorb)oligopeptide, low-fat, isocaloric, non-residue diet | Dietary supplement | Control group |
Primary outcome
Postoperative complication rate
Time frame: 30 days
Complication rate during 30 days after the operation
1 secondary outcome
Overall survival
Time frame: 5 years
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 27 Feb 2019.
- Results publication: PubMed 29533110Scislo L, Pach R, Nowak A, Walewska E, Gadek M, Brandt P, Puto G, Szczepanik AM, Kulig J. The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients - Randomized Clinical Trial. Nutr Cancer. 2018 Apr;70(3):453-459. doi: 10.1080/01635581.2018.1445770. Epub 2018 Mar 13.
- LInk to full text of the article with results summaryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Radosław Pach, MD PhD study chair
1st Dept. of General Surgery, Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunomodulating nutrition (Reconvan) and Standard nutrition (Peptisorb) in people with Gastric 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 5 inclusion and 2 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 27 Feb 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postoperative complication rate (time frame: 30 days). 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 NCT02647476, which also lists 1 linked publication.
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 27 Feb 2019.