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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Angst, Stanford University
ClinicalTrials.gov Identifier:
NCT01885728
First received: June 18, 2013
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Immunity
Dietary Supplement: An arginine rich nutritional supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Intracellular phosphorylation events in MDSCs will be quantified.


Secondary Outcome Measures:
  • Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire. [ Time Frame: Daily for duration of hospital stay, then every 3 days trough postoperative week 5. ] [ Designated as safety issue: No ]
    Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs.


Other Outcome Measures:
  • Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells [ Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. ] [ Designated as safety issue: No ]
  • Functional status of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells [ Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. ] [ Designated as safety issue: No ]
  • Functional potency of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells [ Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. ] [ Designated as safety issue: No ]
  • Capacity of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells [ Time Frame: Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arginine rich nutritional supplement
237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery.
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.
Other Name: 'Impact' made by Nestle Corporation
No Intervention: No nutritional supplement
No specific nutritional requirements have to be met in this group.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885728

Locations
United States, California
Stanford University Hospital
Stanford, California, United States, 84305
Sponsors and Collaborators
Martin Angst
Investigators
Principal Investigator: Martin S Angst, MD Stanford University SOM
  More Information

Responsible Party: Martin Angst, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT01885728     History of Changes
Other Study ID Numbers: 27485 
Study First Received: June 18, 2013
Last Updated: November 4, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 09, 2016