Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • dietary supplement: An arginine rich nutritional supplement

Eligibility


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
   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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Julian Silva, MA
650-724-9341
Not Recruiting