Gastrointestinal MalignantPhase 4ISEENNCT01778166
Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition
A Phase 4 study testing Immuno-enhanced and Standard early enteral nutrition in people with Gastrointestinal Malignant, run by Jinling Hospital, China at 1 site in China.
Trial summary
Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Malignant
- What is being tested?
- Immuno-enhanced and Standard early enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Mar 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable gastric cancer by laparoscope
- Resectable colorectal cancer laparoscope
- Resectable gastrointestinal interstitialoma by laparoscope
Who cannot join
- Locally unresectable tumor
- Metastatic tumor
- Preoperative total parenteral or enteral nutrition
- Lack of the patient's consent for the trial participation
- Previous gastrointestinal resection
Trial locations and contacts
1 site in 1 country.
China1 site
Jinling Hospital
Nanjing, Jiangsu, 210002
Danhua Yao, MD/PhD, 8602580860037
Danhua Yao
About this study
Official title: Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients
Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce.
The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.
- Conditions
- Gastrointestinal Malignant
- Being tested
- Immuno-enhanced, Standard early enteral nutrition
- Keywords
- Early enteral nutrition, Laparoscopic gastrointestinal surgery, Immuno-enhanced nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immuno-enhancedDrug
Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
Standard early enteral nutritionDrug
Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| Standard early enteral nutrition | Active comparator | There would be 100 patients in this group Receives: Drug: Standard early enteral nutrition |
| Immuno-enhanced early enteral nutrition | Experimental | There would 100 patients in this group Receives: Drug: Immuno-enhanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tolerate IEEN/SEEN
Measured: 30 days after operation
Secondary outcomes (8)
Overall morbidity rate of IEEN/SEEN
Measured: 60 days after operation
Mortality rate of IEEN/SEEN after operation
Measured: 60 days after operation
Energy metabolism
Measured: 10 days after operation
Time to the first postoperative adjuvant chemotherapy
Measured: 30 days after operation
Nutritional status in postoperative day1and 7 of IEEN/SEEN
Measured: 7 days after operation
Immune function in postoperative day 1 and 7
Measured: 7 days after operation
Postoperative hospital stay length
Measured: 60 days after operation
Rehospitalization rate
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MalignantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Danhua Yao, Jinling Hospital, China
- Investigators
- Danhua Yao, MD/PhD, Principal investigator, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778166
- Sponsor's protocol ID
- ISEEN001
- Other IDs
- ISEEN
- Acronym
- ISEEN
- Status last verified
- Jan 2013
- First submitted
- 25 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.
PubMed 21628607Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x.
PubMed 22788925Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336.
PubMed 21058198
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients
- ClinicalTrials.gov ID
- NCT01778166
- Acronym / sponsor ID
- ISEEN / ISEEN001
- Conditions
- Gastrointestinal Malignant
- Keywords
- Early enteral nutrition, Laparoscopic gastrointestinal surgery, Immuno-enhanced nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 29 Jan 2013 (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.
Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce.
The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard early enteral nutrition | Active comparator | Drug: Standard early enteral nutritionThere would be 100 patients in this group |
| Immuno-enhanced early enteral nutrition | Experimental | Drug: Immuno-enhancedThere would 100 patients in this group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resectable gastric cancer by laparoscope
- Resectable colorectal cancer laparoscope
- Resectable gastrointestinal interstitialoma by laparoscope
Key exclusion criteria (5 listed)
- Locally unresectable tumor
- Metastatic tumor
- Preoperative total parenteral or enteral nutrition
- Lack of the patient's consent for the trial participation
- Previous gastrointestinal resection
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 |
|---|---|---|
| Immuno-enhancedImmediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube | Drug | Immuno-enhanced early enteral nutrition |
| Standard early enteral nutritionImmediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube | Drug | Standard early enteral nutrition |
Primary outcome
Time to tolerate IEEN/SEEN
Time frame: 30 days after operation
8 secondary outcomes
Overall morbidity rate of IEEN/SEEN
Time frame: 60 days after operation
Mortality rate of IEEN/SEEN after operation
Time frame: 60 days after operation
Energy metabolism
Time frame: 10 days after operation
Time to the first postoperative adjuvant chemotherapy
Time frame: 30 days after operation
Nutritional status in postoperative day1and 7 of IEEN/SEEN
Time frame: 7 days after operation
Immune function in postoperative day 1 and 7
Time frame: 7 days after operation
Postoperative hospital stay length
Time frame: 60 days after operation
Rehospitalization rate
Time frame: 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Background: PubMed 21628607Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.
- Background: PubMed 22788925Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x.
- Background: PubMed 21058198Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336.
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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.
Danhua Yao, MD/PhD principal investigator
Nanjing University
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 Immuno-enhanced and Standard early enteral nutrition in people with Gastrointestinal Malignant, run by Jinling Hospital, China at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danhua Yao, MD/PhD (8602580860961, yaodh87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to tolerate IEEN/SEEN (time frame: 30 days after operation). 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 NCT01778166, which also lists 3 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 31 Jan 2013.