Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery

NCT ID: NCT02987296

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-07-01

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.

Conditions

ColoRectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Immunonutrition with arginine

Intervention Type: DIETARY_SUPPLEMENT

Nutritional beverage containing supplemental arginine taken 3 times per day

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.

Group Type: PLACEBO_COMPARATOR

Immunonutrition without Arginine

Intervention Type: DIETARY_SUPPLEMENT

Nutritional beverage without supplemental arginine taken 3 times per day

Interventions

Immunonutrition with arginine

Nutritional beverage containing supplemental arginine taken 3 times per day

Intervention Type: DIETARY_SUPPLEMENT

Immunonutrition without Arginine

Nutritional beverage without supplemental arginine taken 3 times per day

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca C Auer, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35879482 (View on PubMed)

Other Identifiers

20160732-01H

Identifier Type: -

Identifier Source: org_study_id