ColoRectal CancerPERIOP-02NCT02987296
Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery
A study testing Immunonutrition with arginine and Immunonutrition without Arginine in people with ColoRectal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The immune system plays an important role in helping to kill and prevent cancers. Cells of the immune system, such as natural killer (NK) cells and T cells, do not work as well following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the body. 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?
- Immunonutrition with arginine and Immunonutrition without Arginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 1 Jul 2019
- 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 a diagnosis of a primary colorectal cancer and eligible for surgical resection.
- Patients > 18 years of age
- Eligible patients must have signed a consent for surgical resection of the malignancy.
- Ability to understand and provide a signed informed consent form (ICF) approved by the Research ethics board (REB).
- Adequate kidney function with Creatine clearance>30mL/min
- Hemoglobin level >90 mg/dL
- Ability to comply with protocol requirements.
Who cannot join
- Prior adjuvant chemotherapy or radiation within 8 weeks of planned surgery.
- Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (<7.5 mg daily).
- Subjects with resting hypotension (Blood pressure <90/50 at rest).
- History of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Serious intercurrent chronic or acute illness, or other illness considered by the investigator as an unwarranted high risk for an investigational product.
- Active infection of any site and/or active herpes requiring ongoing treatment
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- Known pregnancy or nursing mothers
- Subjects with a fish allergy.
- Subjects with severe asthma defined as asthma not controlled with inhaled corticosteroids and additional controllers or by oral corticosteroid treatment (arginine can cause allergic response or make swelling in airways worse).
- Subjects with a known inherited guanidinoacetate methyltransferase deficiency (due to an inability to convert arginine to creatine)
- Subject with known history of liver cirrhosis
- Subjects who have who have suffered a myocardial infarction or life-threatening arrhythmia within the last 6 months
- Subjects with cardiac failure or coronary artery disease causing unstable angina
- Subjects with a medical or psychological impediment to probable compliance with the protocol should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Translational Clinical Trial of Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery: PERIOP-02
The immune system plays an important role in helping to kill and prevent cancers. Cells of the immune system, such as natural killer (NK) cells and T cells, do not work as well following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the body. Surgery has shown to cause a reduction of arginine in the body. In turn, this deficiency causes NK cell suppression. In this study, we want to look at the effects of arginine supplementation before and after surgery on NK cell function in surgery patients. In this study, we will be using a nutritional supplement containing arginine and a placebo drink (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5 days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK cell levels, arginine levels and also arginase activity.
- Conditions
- ColoRectal Cancer
- Being tested
- Immunonutrition with arginine, Immunonutrition without Arginine
- Keywords
- Colorectal Cancer, Surgery, Arginine depletion, Immune system dysfunction, Arginine Supplementation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunonutrition with arginineDietary supplement
Nutritional beverage containing supplemental arginine taken 3 times per day
Immunonutrition without ArginineDietary supplement
Nutritional beverage without supplemental arginine taken 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition with arginine | Active comparator | Patients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain arginine. Receives: Dietary Supplement: Immunonutrition with arginine |
| Immunonutrition without arginine | Placebo comparator | This group of patients will also receive a nutritional drink but containing no arginine for 5 days before surgery and for 5 days after surgery. Receives: Dietary Supplement: Immunonutrition without Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK cell killing as measured on peripheral blood mononuclear cells (PBMC) between the control (placebo) and experimental cohorts, using a standard NK cell killing assay.
Measured: Baseline (before surgery), post-operative day 1
Secondary outcomes (2)
Decrease in postoperative serum arginine levels between the control (placebo) and experimental cohorts
Measured: Baseline (before surgery), post-operative day 1, 3, 5 and 35
Compliance with perioperative arginine supplementation
Measured: 5 days preoperatively to 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
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 ColoRectal CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca C Auer, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987296
- Sponsor's protocol ID
- 20160732-01H
- Acronym
- PERIOP-02
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Angka L, Martel AB, Ng J, Pecarskie A, Sadiq M, Jeong A, Scaffidi M, Tanese de Souza C, Kennedy MA, Tadros S, Auer RC. A Translational Randomized Trial of Perioperative Arginine Immunonutrition on Natural Killer Cell Function in Colorectal Cancer Surgery Patients. Ann Surg Oncol. 2022 Nov;29(12):7410-7420. doi: 10.1245/s10434-022-12202-y. Epub 2022 Jul 25.
PubMed 35879482
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Clinical Trial of Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery: PERIOP-02
- ClinicalTrials.gov ID
- NCT02987296
- Acronym / sponsor ID
- PERIOP-02 / 20160732-01H
- Conditions
- ColoRectal Cancer
- Keywords
- Colorectal Cancer, Surgery, Arginine depletion, Immune system dysfunction, Arginine Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 8 Dec 2016 (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 immune system plays an important role in helping to kill and prevent cancers. Cells of the immune system, such as natural killer (NK) cells and T cells, do not work as well following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the body. Surgery has shown to cause a reduction of arginine in the body. In turn, this deficiency causes NK cell suppression. In this study, we want to look at the effects of arginine supplementation before and after surgery on NK cell function in surgery patients. In this study, we will be using a nutritional supplement containing arginine and a placebo drink (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5 days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK cell levels, arginine levels and also arginase activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition with arginine | Active comparator | Dietary Supplement: Immunonutrition with argininePatients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain arginine. |
| Immunonutrition without arginine | Placebo comparator | Dietary Supplement: Immunonutrition without ArginineThis group of patients will also receive a nutritional drink but containing no arginine for 5 days before surgery and for 5 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of a primary colorectal cancer and eligible for surgical resection.
- Patients > 18 years of age
- Eligible patients must have signed a consent for surgical resection of the malignancy.
- Ability to understand and provide a signed informed consent form (ICF) approved by the Research ethics board (REB).
- Adequate kidney function with Creatine clearance>30mL/min
Key exclusion criteria (14 listed)
- Prior adjuvant chemotherapy or radiation within 8 weeks of planned surgery.
- Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (<7.5 mg daily).
- Subjects with resting hypotension (Blood pressure <90/50 at rest).
- History of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Serious intercurrent chronic or acute illness, or other illness considered by the investigator as an unwarranted high risk for an investigational product.
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 |
|---|---|---|
| Immunonutrition with arginineNutritional beverage containing supplemental arginine taken 3 times per day | Dietary supplement | Immunonutrition with arginine |
| Immunonutrition without ArginineNutritional beverage without supplemental arginine taken 3 times per day | Dietary supplement | Immunonutrition without arginine |
Primary outcome
NK cell killing as measured on peripheral blood mononuclear cells (PBMC) between the control (placebo) and experimental cohorts, using a standard NK cell killing assay.
Time frame: Baseline (before surgery), post-operative day 1
2 secondary outcomes
Decrease in postoperative serum arginine levels between the control (placebo) and experimental cohorts
Time frame: Baseline (before surgery), post-operative day 1, 3, 5 and 35
Compliance with perioperative arginine supplementation
Time frame: 5 days preoperatively to 5 days postoperatively
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 6 Sep 2019.
- Derived from this study: PubMed 35879482Angka L, Martel AB, Ng J, Pecarskie A, Sadiq M, Jeong A, Scaffidi M, Tanese de Souza C, Kennedy MA, Tadros S, Auer RC. A Translational Randomized Trial of Perioperative Arginine Immunonutrition on Natural Killer Cell Function in Colorectal Cancer Surgery Patients. Ann Surg Oncol. 2022 Nov;29(12):7410-7420. doi: 10.1245/s10434-022-12202-y. Epub 2022 Jul 25.
- Individual participant dataSharing planned: Yes
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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.
Rebecca C Auer, MD, MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition with arginine and Immunonutrition without Arginine in people with ColoRectal Cancer, run by Ottawa Hospital Research Institute 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 7 inclusion and 14 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 6 Sep 2019. 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?
NK cell killing as measured on peripheral blood mononuclear cells (PBMC) between the control (placebo) and experimental cohorts, using a standard NK cell killing assay. (time frame: Baseline (before surgery), post-operative day 1). 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 NCT02987296, 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 6 Sep 2019.