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

Immunity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885728
• Other study ID #: 27485
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: November 4, 2016
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Immunity

Intervention

Dietary Supplement:
• An arginine rich nutritional supplement
Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.

Locations

Country	Name	City	State
United States	Stanford University Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Martin Angst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells		Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.	No
Other	Functional status of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells		Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.	No
Other	Functional potency of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells		Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.	No
Other	Capacity of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells		Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.	No
Primary	Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline.	The fraction of MDSCs will be quantified.	Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.	No
Primary	Functional status change of myeloid-derived suppressor cells (MDSC) from baseline.	Intracellular phosphorylation events in MDSCs will be quantified.	Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery.	No
Secondary	Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire.	Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs.	Daily for duration of hospital stay, then every 3 days trough postoperative week 5.	No