Clinical trial NCT01885728: Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.
timeFrame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
measure: Functional status change of myeloid-derived suppressor cells (MDSC) from baseline.
timeFrame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Secondary outcomes:
measure: Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire.
timeFrame: Daily for duration of hospital stay, then every 3 days trough postoperative week 5.
Other outcomes:
measure: Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells
timeFrame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
measure: Functional status of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells
timeFrame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
measure: Functional potency of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells
timeFrame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
measure: Capacity of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells
timeFrame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University SOM
name: Martin S Angst, MD
role: PRINCIPAL_INVESTIGATOR
References: