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Completed

NCT Number: NCT01885728

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

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.

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Key information

Conditions

Immunity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Hospital

Stanford, California, 84305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Patients with Hx of substance abuse (e.g., alcoholism, drug dependency)
  • Undernourished patients as indicated by a weight loss >10% during the last 6 months
  • Patients with galactosemia
  • Patients who had undergone previous major abdominal surgery
  • 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
  • Pregnancy
  • Other conditions compromising a participant's safety or the integrity of the study

Treatment and study plan

An arginine rich nutritional supplement

Dietary Supplement

Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.

Other names: 'Impact' made by Nestle Corporation

Primary outcomes

  1. 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.

  2. 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

  1. 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.

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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Martin Angst

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2013
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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