Status:
COMPLETED
Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
Lead Sponsor:
Martin Angst
Conditions:
Immunity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ci...
Eligibility Criteria
Inclusion
- Colon surgery for cancer
- Patients ≥ 18 and ≤65 years of age
- 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
- Patients on immune-suppressant therapy within the last 6 months (e.g. azathioprine or cyclosporine)
- Patients pretreated (6 months) or currently on chemotherapy for cancer
- Patients on radiation therapy (within 6 months)
- Patients on chronic medication with potential immune-modulatory effects (e.g. daily oral morphine-equivalent intake \> 30 mg)
- Patients with metastatic disease
- Patients with active infectious disease (within 2 months)
- Patients with significant metabolic disease (e.g. diabetes type I)
- Patients with clinically significant organ dysfunction including renal and hepatic dysfunction
- Patients with significant cardiovascular and respiratory comorbidities resulting in impaired function and frailty
- Patients with autoimmune disease (e.g. lupus)
- Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
- Undernourished patients as indicated by a weight loss \>10% during the last 6 months
- Patients with galactosemia
- Patients who had undergone previous major abdominal surgery
- 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
- Pregnancy
- Other conditions compromising a participant's safety or the integrity of the study
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01885728
Start Date
July 1 2013
End Date
June 1 2016
Last Update
November 7 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University Hospital
Stanford, California, United States, 84305