Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients

Not Applicable

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: An arginine rich nutritional supplement

• Registration Number: NCT01885728
• Lead Sponsor: Martin Angst

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-25
• Study Start: 2013-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arginine rich nutritional supplement	An arginine rich nutritional supplement	237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery.

Primary Outcome Measures

Name	Time	Method
Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.	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.	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 Outcome Measures

Name	Time	Method
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.	Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs.

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States