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

Not Recruiting

Trial ID: NCT01885728


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

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

Stanford Investigator(s)

Martin S. Angst
Martin S. Angst

Professor of Anesthesiology, Perioperative and Pain Medicine

Brice Gaudilliere
Brice Gaudilliere

Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Adult-MSD) and, by courtesy, of Pediatrics (Neonatology)


Inclusion Criteria:

   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

Exclusion Criteria:

   1. Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or

   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

   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

16. Pregnancy

17. Other conditions compromising a participant's safety or the integrity of the study


dietary supplement: An arginine rich nutritional supplement

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Julian Silva, MA