Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
Trial ID or NCT#
NCT01885728
Status
NOT RECRUITING
Purpose
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Colon surgery for cancer2. Patients ≥ 18 and ≤65 years of age3. 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 cancer3. 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 disease6. 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 dysfunction9. Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty10. 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 months13. Patients with galactosemia14. Patients who had undergone previous major abdominal surgery15. 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 study16. Pregnancy17. Other conditions compromising a participant's safety or the integrity of the study
Investigator(s)
Brice Gaudilliere
Anesthesiologist
Associate Professor of Anesthesiology, Perioperative and Pain Medicine (MSD) and, by courtesy, of Pediatrics (Neonatology)
Contact us to find out if this trial is right for you.
Contact
Julian Silva, MA
650-724-9341
View on ClinicalTrials.gov
