Gastrointestinal CancerIPOD-3NCT01023412
Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery
A study testing Immunonutrition in people with Gastrointestinal Cancer, run by Société des Produits Nestlé (SPN) at 6 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Immunonutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Jan 2006to May 2008
- Phase
- Interventional
- 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
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Kantonsspital Aarau
Aarau, 5001
Kantonsspital Baden
Baden, 5404
Lindenhof-Spital
Bern, 3012
Kantonsspital Liestal
Liestal, 4410
Kantonsspital St.Gallen
Sankt Gallen, 9000
Kantonsspital Schaffausen
Schaffhausen, 8208
About this study
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
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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Immunonutrition
- Keywords
- Immunonutrition, cancer, GI cancer surgery
- Medical subject headings
- Gastrointestinal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
| Study group | Role | What they receive |
|---|---|---|
| Nutritional product | Active comparator | Oral nutritional supplement containing immuno nutrients Receives: Dietary Supplement: Immunonutrition |
| Isocaloric control | Placebo comparator | Isocaloric and isonitrogenous control without immuno nutrients Receives: Dietary Supplement: Immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative complications
Measured: On the day of discharge from hospital
Secondary outcomes (4)
Incidence of non-infectious complications
Measured: On the day of discharge from hospital
Length of hospital stay
Measured: On the day of discharge from hospital
Nutritional status evaluation
Measured: On the day of discharge from hospital
Rate of post-operative infectious complications
Measured: On the day of discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023412
- Sponsor's protocol ID
- SC-IRTD-01-05-CH
- Acronym
- IPOD-3
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2009
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01023412
- Acronym / sponsor ID
- IPOD-3 / SC-IRTD-01-05-CH
- Conditions
- Gastrointestinal Cancer
- Keywords
- Immunonutrition, cancer, GI cancer surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Dec 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional product | Active comparator | Dietary Supplement: ImmunonutritionOral nutritional supplement containing immuno nutrients |
| Isocaloric control | Placebo comparator | Dietary Supplement: ImmunonutritionIsocaloric and isonitrogenous control without immuno nutrients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| ImmunonutritionOral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA). | Dietary supplement | Isocaloric control, Nutritional product |
Primary outcome
Rate of post-operative complications
Time frame: On the day of discharge from hospital
4 secondary outcomes
Incidence of non-infectious complications
Time frame: On the day of discharge from hospital
Length of hospital stay
Time frame: On the day of discharge from hospital
Nutritional status evaluation
Time frame: On the day of discharge from hospital
Rate of post-operative infectious complications
Time frame: On the day of discharge from hospital
Results and safety
The study was stopped early (reason given: interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition in people with Gastrointestinal Cancer, run by Société des Produits Nestlé (SPN) at 6 sites in Switzerland.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.). Results are not available in the source record.
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?
Rate of post-operative complications (time frame: On the day of discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.