A Randomized, Controlled Study Evaluating the Immune-Modulatory Effects of Perioperative Administration of Arginine Rich Nutritional Supplements With Mass Cytometry in Patient Undergoing Surgery
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Martin Angst
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.
Overview
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 circulating immune cells will be assessed with mass cytometry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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)
Outcomes
Primary Outcomes
Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
The fraction of MDSCs will be quantified.
Functional status change of myeloid-derived suppressor cells (MDSC) from baseline.
Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Intracellular phosphorylation events in MDSCs will be quantified.
Secondary Outcomes
- Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire.(Daily for duration of hospital stay, then every 3 days trough postoperative week 5.)
Investigators
Martin Angst
Professor of Anesthesia
Stanford University