Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients

Study Overview
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Brief Summary
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The primary objective of this study is to characterize the immune-modulatory effects of arginine-rich nutritional supplements in patients undergoing surgery. Numerical and functional changes of all circulating immune cells will be assessed with mass cytometry.

Official Title
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A Randomized, Controlled Study Evaluating the Immune-Modulatory Effects of Perioperative Administration of Arginine Rich Nutritional Supplements With Mass Cytometry in Patient Undergoing Surgery

Conditions
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Immunity

Intervention / Treatment
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* Dietary Supplement: An arginine rich nutritional supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colon surgery for cancer Patients ≥ 18 and ≤65 years of age Patients willing and able to sign an informed consent form and Health Insurance and Portability Act (HIPAA) authorization and to comply with study procedures Exclusion Criteria: Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine) Patients pretreated (6 months) or currently on chemotherapy for cancer Patients on radiation therapy (within 6 months) Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake > 30 mg) Patients with metastatic disease Patients with active infectious disease (within 2 months) Patients with significant metabolic disease (e.g. diabetes type I) Patients with clinically significant organ dysfunction including renal and hepatic dysfunction Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty Patients with autoimmune disease (e.g. lupus) Patients with Hx of substance abuse (e.g., alcoholism, drug dependency) Undernourished patients as indicated by a weight loss >10% during the last 6 months Patients with galactosemia Patients who had undergone previous major abdominal surgery Participation in another clinical trial of an investigational drug or device within the last 30 days prior to the first day of study that, in the investigator's opinion, would create increased risk to the participant or compromise the integrity or either study Pregnancy Other conditions compromising a participant's safety or the integrity of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arginine rich nutritional supplement<br>237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery. | Dietary Supplement: An arginine rich nutritional supplement<br>* Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.<br>* Other names: 'Impact' made by Nestle Corporation;|
| No Intervention: No nutritional supplement<br>No specific nutritional requirements have to be met in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline. | The fraction of MDSCs will be quantified. | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. | 
| Functional status change of myeloid-derived suppressor cells (MDSC) from baseline. | Intracellular phosphorylation events in MDSCs will be quantified. | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire. | Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs. | Daily for duration of hospital stay, then every 3 days trough postoperative week 5. |