Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
Trial ID or NCT#
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.
A Randomized, Controlled Study Evaluating the Immune-Modulatory Effects of Perioperative Administration of Arginine Rich Nutritional Supplements With Mass Cytometry in Patient Undergoing Surgery
- 1. Colon surgery for cancer 2. Patients ≥ 18 and ≤65 years of age 3. Patients willing and able to sign an informed consent form and Health Insurance and Portability Act (HIPAA) authorization and to comply with study procedures
- 1. Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine) 2. Patients pretreated (6 months) or currently on chemotherapy for cancer 3. Patients on radiation therapy (within 6 months) 4. Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake > 30 mg) 5. Patients with metastatic disease 6. Patients with active infectious disease (within 2 months) 7. Patients with significant metabolic disease (e.g. diabetes type I) 8. Patients with clinically significant organ dysfunction including renal and hepatic dysfunction 9. Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty 10. Patients with autoimmune disease (e.g. lupus) 11. Patients with Hx of substance abuse (e.g., alcoholism, drug dependency) 12. Undernourished patients as indicated by a weight loss >10% during the last 6 months 13. Patients with galactosemia 14. Patients who had undergone previous major abdominal surgery 15. 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 16. Pregnancy 17. Other conditions compromising a participant's safety or the integrity of the study
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Julian Silva, MA