Pancreatic CancerNCT01789073
Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay
A study testing Oral Impact, Nestlé Health Science in people with Pancreatic Cancer, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Oral Impact, Nestlé Health Science
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Dec 2013
- 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
- Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
- Age > 18 years.
Who cannot join
- Age < 18 years
- Pregnant and lactating women
- Persons who cannot understand and/or speak Danish
- Renal dysfunction
- Milk allergy
- Participants are excluded if elective surgery is not indicated after all
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer
The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.
- Conditions
- Pancreatic Cancer
- Being tested
- Oral Impact, Nestlé Health Science
- Keywords
- Postoperative, Complications, Elective, Surgery, GI surgery, Immunonutrition, Immune-enhancing, Immune-modulating, Nutrition, Pancreatic cancer, Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.
- Medical subject headings
- Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Impact, Nestlé Health ScienceDietary supplement
Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Oral Impact, Nestlé Health Science | Experimental | Oral Impact-arm receives the intervention the last 7 days prior to surgery Receives: Dietary Supplement: Oral Impact, Nestlé Health Science |
| Control | No intervention | The control-arm receives no intervention but is treated according to the standard procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall postoperative complications after major gastrointestinal (GI) elective surgery.
Measured: Within the first 30 days after surgery
Secondary outcomes (1)
Length of hospital stay after major gastrointestinal (GI) elective surgery
Measured: Within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
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 Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Jens R Andersen, Chief Phys., Ass. Prof., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789073
- Sponsor's protocol ID
- H-1-2012-146
- Status last verified
- Dec 2013
- First submitted
- 7 Feb 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gade J, Levring T, Hillingso J, Hansen CP, Andersen JR. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial. Nutr Cancer. 2016;68(2):225-33. doi: 10.1080/01635581.2016.1142586. Epub 2016 Mar 4.
PubMed 26943500
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01789073
- Acronym / sponsor ID
- H-1-2012-146
- Conditions
- Pancreatic Cancer
- Keywords
- Postoperative, Complications, Elective, Surgery, GI surgery, Immunonutrition, Immune-enhancing, Immune-modulating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Feb 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.
The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Impact, Nestlé Health Science | Experimental | Dietary Supplement: Oral Impact, Nestlé Health ScienceOral Impact-arm receives the intervention the last 7 days prior to surgery |
| Control | No intervention | –The control-arm receives no intervention but is treated according to the standard procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
- Age > 18 years.
Key exclusion criteria (6 listed)
- Age < 18 years
- Pregnant and lactating women
- Persons who cannot understand and/or speak Danish
- Renal dysfunction
- Milk allergy
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 |
|---|---|---|
| Oral Impact, Nestlé Health ScienceOral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery. | Dietary supplement | Oral Impact, Nestlé Health Science |
Primary outcome
Overall postoperative complications after major gastrointestinal (GI) elective surgery.
Time frame: Within the first 30 days after surgery
1 secondary outcome
Length of hospital stay after major gastrointestinal (GI) elective surgery
Time frame: Within the first 30 days after surgery
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 23 Dec 2013.
- Derived from this study: PubMed 26943500Gade J, Levring T, Hillingso J, Hansen CP, Andersen JR. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial. Nutr Cancer. 2016;68(2):225-33. doi: 10.1080/01635581.2016.1142586. Epub 2016 Mar 4.
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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.
Jens R Andersen, Chief Phys., Ass. Prof. principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Impact, Nestlé Health Science in people with Pancreatic Cancer, run by University of Copenhagen at 1 site in Denmark.
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 2 inclusion and 6 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 23 Dec 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 Denmark. 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.
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?
Overall postoperative complications after major gastrointestinal (GI) elective surgery. (time frame: Within the first 30 days after surgery). 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 NCT01789073, 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 23 Dec 2013.