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

Primary Purpose

ColoRectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Immunonutrition with arginine

Immunonutrition without Arginine

About this trial

This is an interventional treatment trial for ColoRectal Cancer focused on measuring Colorectal Cancer, Surgery, Arginine depletion, Immune system dysfunction, Arginine Supplementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Immunonutrition with arginine

Immunonutrition without arginine

Arm Description

Patients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decrease in postoperative serum arginine levels between the control (placebo) and experimental cohorts

Compliance with perioperative arginine supplementation

Full Information

NCT ID

NCT02987296

First Posted

October 25, 2016

Last Updated

September 3, 2019

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02987296

Brief Title

Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery

Acronym

PERIOP-02

Official Title

A Translational Clinical Trial of Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery: PERIOP-02

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

June 1, 2019 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ColoRectal Cancer

Keywords

Colorectal Cancer, Surgery, Arginine depletion, Immune system dysfunction, Arginine Supplementation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immunonutrition with arginine

Arm Type

Active Comparator

Arm Description

Patients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain arginine.

Arm Title

Immunonutrition without arginine

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Immunonutrition with arginine

Intervention Description

Nutritional beverage containing supplemental arginine taken 3 times per day

Intervention Type

Dietary Supplement

Intervention Name(s)

Immunonutrition without Arginine

Intervention Description

Nutritional beverage without supplemental arginine taken 3 times per day

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

Compliance with perioperative arginine supplementation

Time Frame

5 days preoperatively to 5 days postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca C Auer, MD, MSc

Organizational Affiliation

Ottawa Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

35879482

Citation

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.

Results Reference

derived

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Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery

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