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Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery (PERIOP-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02987296
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
ColoRectal Cancer Dietary Supplement: Immunonutrition with arginine Dietary Supplement: Immunonutrition without Arginine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Translational Clinical Trial of Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery: PERIOP-02
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Immunonutrition with arginine
Patients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain arginine.
Dietary Supplement: Immunonutrition with arginine
Nutritional beverage containing supplemental arginine taken 3 times per day

Placebo Comparator: Immunonutrition without arginine
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.
Dietary Supplement: Immunonutrition without Arginine
Nutritional beverage without supplemental arginine taken 3 times per day




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Compliance with perioperative arginine supplementation [ Time Frame: 5 days preoperatively to 5 days postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987296


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Rebecca C Auer, MD, MSc Ottawa Hospital Research Institute

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02987296     History of Changes
Other Study ID Numbers: 20160732-01H
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Colorectal Cancer
Surgery
Arginine depletion
Immune system dysfunction
Arginine Supplementation
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases