Colon CancerNCT01222208
Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients
A study testing Oral Nutrition with dextrose and pressurized whey protein and Peripheral Parenteral Nutrition in people with Colon Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Oral Nutrition with dextrose and pressurized whey protein and Peripheral Parenteral Nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Nov 2011
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The American Society of Anesthesiologists' (ASA) class 1 to 3
- Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- Nutrition status: 18.5 < body mass index < 30 kg/m2, stable weight over the preceding three months (< 10% body weight loss), serum albumin > 35g/l
Who cannot join
- History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
- Renal impairment (Serum Creatinine outside normal range)
- Cardiac failure (New York Heart Association (NYHA) classes I-IV)
- Hepatic, Renal, Cardiac transplant
- Endocrine disorders: diabetes type I \& II, hyper and hypothyroidism
- Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
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- Musculoskeletal or neuromuscular disease
- Anemia defined as hematocrit < 30, hemoglobin < 10 g/dl, albumin < 25 mg/dl
- Previous spine surgery or scoliosis limiting use of epidural
- Pregnancy
- Use of Steroids
- Milk protein allergy or intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients
A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.
- Conditions
- Colon Cancer
- Being tested
- Oral Nutrition with dextrose and pressurized whey protein, Peripheral Parenteral Nutrition
- Keywords
- Bowel resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutrition with dextrose and pressurized whey proteinDietary supplement
Ten (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day.
Peripheral Parenteral NutritionDietary supplement
Ten (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutrition | Active comparator | Subjects will receive an oral nutrition regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as pressurized whey protein Receives: Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein |
| Peripheral Parenteral Nutrition | Placebo comparator | Subjects will receive a peripheral parenteral nutrition (PPN) regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as amino acids. Receives: Dietary Supplement: Peripheral Parenteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body protein balance
Whole body protein balance (the difference between protein synthesis and protein breakdown) as assessed by the kinetics of a stable, non-radioactive, isotope tracer infusion of L-[1-13C] leucine
Measured: 1 year
Secondary outcomes (1)
Synthesis rates of hepatic secretory proteins
Synthesis rates of hepatic secretory proteins, including the classically positive acute phase reactant fibrinogen and the classically negative acute phase reactant albumin, as assessed by incorporation of the stable, non-radioactive, isotope tracer L-[2H5] phenylalanine into plasma Very Low Density Lipoprotein ApolipoproteinB100.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionNov 2011
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 Colon 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- Montreal General Hospital, McGill University
- Responsible party
- Principal investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222208
- Sponsor's protocol ID
- 10-106-GEN
- Status last verified
- Feb 2012
- First submitted
- 14 Oct 2010
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schricker T, Meterissian S, Lattermann R, Adegoke OA, Marliss EB, Mazza L, Eberhart L, Carli F, Nitschman E, Wykes L. Anticatabolic effects of avoiding preoperative fasting by intravenous hypocaloric nutrition: a randomized clinical trial. Ann Surg. 2008 Dec;248(6):1051-9. doi: 10.1097/SLA.0b013e31818842d8.
PubMed 19092350
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients
- ClinicalTrials.gov ID
- NCT01222208
- Acronym / sponsor ID
- 10-106-GEN
- Conditions
- Colon Cancer
- Keywords
- Bowel resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Montreal General Hospital, McGill University
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Oct 2010 (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.
A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nutrition | Active comparator | Dietary Supplement: Oral Nutrition with dextrose and pressurized whey proteinSubjects will receive an oral nutrition regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as pressurized whey protein |
| Peripheral Parenteral Nutrition | Placebo comparator | Dietary Supplement: Peripheral Parenteral NutritionSubjects will receive a peripheral parenteral nutrition (PPN) regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as amino acids. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The American Society of Anesthesiologists' (ASA) class 1 to 3
- Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- Nutrition status: 18.5 < body mass index < 30 kg/m2, stable weight over the preceding three months (< 10% body weight loss), serum albumin > 35g/l
Key exclusion criteria (12 listed)
- History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
- Renal impairment (Serum Creatinine outside normal range)
- Cardiac failure (New York Heart Association (NYHA) classes I-IV)
- Hepatic, Renal, Cardiac transplant
- Endocrine disorders: diabetes type I \& II, hyper and hypothyroidism
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 Nutrition with dextrose and pressurized whey proteinTen (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day. | Dietary supplement | Oral Nutrition |
| Peripheral Parenteral NutritionTen (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day. | Dietary supplement | Peripheral Parenteral Nutrition |
Primary outcome
Whole body protein balance
Time frame: 1 year
Whole body protein balance (the difference between protein synthesis and protein breakdown) as assessed by the kinetics of a stable, non-radioactive, isotope tracer infusion of L-[1-13C] leucine
1 secondary outcome
Synthesis rates of hepatic secretory proteins
Time frame: 1 year
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 7 Feb 2012.
- Results publication: PubMed 19092350Schricker T, Meterissian S, Lattermann R, Adegoke OA, Marliss EB, Mazza L, Eberhart L, Carli F, Nitschman E, Wykes L. Anticatabolic effects of avoiding preoperative fasting by intravenous hypocaloric nutrition: a randomized clinical trial. Ann Surg. 2008 Dec;248(6):1051-9. doi: 10.1097/SLA.0b013e31818842d8.
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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.
Franco Carli, M.D. 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 study testing Oral Nutrition with dextrose and pressurized whey protein and Peripheral Parenteral Nutrition in people with Colon 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 3 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: finished, as of the sponsor's last update on 7 Feb 2012. 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.
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?
Whole body protein balance (time frame: 1 year). 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 NCT01222208, 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 7 Feb 2012.