Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
Completed · Not applicable
Conditions studied: Immunity
In brief
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.
Key facts
- Study ID
- NCT01885728
- Run by
- Martin Angst
- People needed
- 22
- Starts
- 2013-07-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-11-07
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University Hospital — Stanford, California, United States
Full record on ClinicalTrials.gov
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