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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT01885728
A Randomized, Controlled Study Evaluating the Immune-Modulatory Effects of Perioperative Administration of Arginine Rich Nutritional Supplements With Mass Cytometry in Patient Undergoing Surgery
Professor of Anesthesiology, Perioperative and Pain Medicine
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
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
dietary supplement: An arginine rich nutritional supplement
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Julian Silva, MA
650-724-9341