Colorectal CancerPhase 4NCT02032953
Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
A Phase 4 study testing Travasol (amino acid injection) and Insulin in people with Colorectal Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Travasol (amino acid injection) and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class<3
- age>18 years
- colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection
- ability to give informed consent
Who cannot join
- BMI>30 Kg/meter squared
- confirmed diagnosis of diabetes mellitus or a HbA1c>6.0%
- significant cardiorespiratory, hepatic, renal and neurological disease
- musculoskeletal or neuromuscular disease
- ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids)
- severe anemia (hemoglobin<10 g/dL
- pregnancy
- history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, H8A1A1
About this study
The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
- Conditions
- Colorectal Cancer
- Being tested
- Travasol (amino acid injection), Insulin
- Keywords
- colorectal cancer, protein recovery, perioperative nutrition, hyperinsulinemia, normoglycemia, hyperinsulinemic-normoglycemic clamp, anabolism
- Medical subject headings
- Colorectal Neoplasms, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travasol (amino acid injection)Dietary supplement
Also called Travasol
an amino acid supplementation infused intravenously containing essential and non-essential amino acids
InsulinDrug
Also called HNC, Hyperinsulinemic-normoglycemic clamp
After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg*min. Ten minuts after starting the insulin, and when the the blood glucose is<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.
| Study group | Role | What they receive |
|---|---|---|
| Insulin, Travasol (35%) postop | Experimental | Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, . Receives: Dietary Supplement: Travasol (amino acid injection); Drug: Insulin |
| Insulin, Travasol (20%) postop | Experimental | Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery. Receives: Dietary Supplement: Travasol (amino acid injection); Drug: Insulin |
| Insulin, no protein after surgery | Placebo comparator | Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net protein balance
The difference in total body protein after randomization to one of the three treatment arms.
Measured: 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2024
- Study completionApr 2024
Why it stopped: organisational problems
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Thomas Schricker, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Thomas Schricker, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032953
- Sponsor's protocol ID
- 12-459-GEN
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Schricker T, Meterissian S, Wykes L, Eberhart L, Lattermann R, Carli F. Postoperative protein sparing with epidural analgesia and hypocaloric dextrose. Ann Surg. 2004 Nov;240(5):916-21. doi: 10.1097/01.sla.0000143249.93856.66.
PubMed 15492576Schricker T, Wykes L, Carli F. Epidural blockade improves substrate utilization after surgery. Am J Physiol Endocrinol Metab. 2000 Sep;279(3):E646-53. doi: 10.1152/ajpendo.2000.279.3.E646.
PubMed 10950834Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PubMed 37526194
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
- ClinicalTrials.gov ID
- NCT02032953
- Acronym / sponsor ID
- 12-459-GEN
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, protein recovery, perioperative nutrition, hyperinsulinemia, normoglycemia, hyperinsulinemic-normoglycemic clamp, anabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: organisational problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2013
- Primary completion
- Apr 2024 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 10 Jan 2014 (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 find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin, Travasol (35%) postop | Experimental | Dietary Supplement: Travasol (amino acid injection), Drug: InsulinInsulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, . |
| Insulin, Travasol (20%) postop | Experimental | Dietary Supplement: Travasol (amino acid injection), Drug: InsulinInsulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery. |
| Insulin, no protein after surgery | Placebo comparator | Drug: InsulinInsulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists class<3
- age>18 years
- colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection
- ability to give informed consent
Key exclusion criteria (8 listed)
- BMI>30 Kg/meter squared
- confirmed diagnosis of diabetes mellitus or a HbA1c>6.0%
- significant cardiorespiratory, hepatic, renal and neurological disease
- musculoskeletal or neuromuscular disease
- ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids)
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 |
|---|---|---|
| Travasol (amino acid injection)Also: Travasolan amino acid supplementation infused intravenously containing essential and non-essential amino acids | Dietary supplement | Insulin, Travasol (20%) postop, Insulin, Travasol (35%) postop |
| InsulinAlso: HNC, Hyperinsulinemic-normoglycemic clampAfter the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg*min. Ten minuts after starting the insulin, and when the the blood glucose is<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study. | Drug | Insulin, Travasol (20%) postop, Insulin, Travasol (35%) postop, Insulin, no protein after surgery |
Primary outcome
Net protein balance
Time frame: 6 hours after surgery
The difference in total body protein after randomization to one of the three treatment arms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 15492576Schricker T, Meterissian S, Wykes L, Eberhart L, Lattermann R, Carli F. Postoperative protein sparing with epidural analgesia and hypocaloric dextrose. Ann Surg. 2004 Nov;240(5):916-21. doi: 10.1097/01.sla.0000143249.93856.66.
- Results publication: PubMed 10950834Schricker T, Wykes L, Carli F. Epidural blockade improves substrate utilization after surgery. Am J Physiol Endocrinol Metab. 2000 Sep;279(3):E646-53. doi: 10.1152/ajpendo.2000.279.3.E646.
- Derived from this study: PubMed 37526194Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
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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.
Thomas Schricker, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 Travasol (amino acid injection) and Insulin in people with Colorectal Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 8 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: withdrawn, as of the sponsor's last update on 8 Oct 2026. 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 Canada. 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Net protein balance (time frame: 6 hours 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 NCT02032953, 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 8 Oct 2026.