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Trial record 9 of 3324 for:    Louisville

Preoperative Nutrition With Immune Enhancing Nutritional Supplement (Immunomodulation)

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ClinicalTrials.gov Identifier: NCT02838966
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
Prejesh Philips, University of Louisville

Brief Summary:
The purpose of this study is to determine the optimal effective dose for preoperative nutritional supplementation with immunomodulators on immune function and perioperative outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Dietary Supplement: Nestle IMPACT Advanced Recovery Dietary Supplement: Nestle Boost High Protein Drink Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Preoperative Nutritional Supplementation With Immunomodulators for Patients With Resectable Pancreatic Adenocarcinoma: Efficacy and Optimal Dose
Study Start Date : August 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Nestle IMPACT Advanced Recovery 1
1 can per day for 5 days prior to surgery
Dietary Supplement: Nestle IMPACT Advanced Recovery
Active Comparator: Nestle IMPACT Advanced Recovery 2
2 cans per day for 5 days prior to surgery
Dietary Supplement: Nestle IMPACT Advanced Recovery
Active Comparator: Nestle IMPACT Advanced Recovery 3
3 cans per day for 5 days prior to surgery
Dietary Supplement: Nestle IMPACT Advanced Recovery
Active Comparator: Nestle Boost High Protein Drink - Control Arm
4 cans per day for 5 days prior to surgery
Dietary Supplement: Nestle Boost High Protein Drink



Primary Outcome Measures :
  1. Change in levels of circulating Myeloid derived suppressor cells [ Time Frame: Within 2 weeks of study intervention (at pre-anesthesia visit) to surgery. Study intervention to start 5 days before surgery ]

    The variable that will be compared in this analysis will be

    • Change in circulating Myeloid derived suppressor cells before and after intervention (before intervention: within 2 weeks before surgery; after intervention: day of surgery)


  2. Overall morbidity rate. [ Time Frame: 30 day morbidity from surgery ]

    The variables that will be compared in this analysis will be

    • overall morbidity rate (adverse effects): number of patients with adverse effects and total number of adverse effects as assessed by CTCAE v4.0 (which includes number of patients with serious adverse effects: Grade 3 or higher, CTCAE v4.0 and number of patients with infectious complication rates)



Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 90 days from surgery ]
    Tolerability of supplement: as defined as ability to complete the nutritional intervention using a patient log.

  2. Hospital length of stay [ Time Frame: 90 days from surgery ]
    Length of hospital stay (in days)

  3. Change in serum arginine levels [ Time Frame: Within 2 weeks of study intervention (at pre-anesthesia visit) to surgery. Study intervention to start 5 days before surgery ]
    Arginine level assay



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age, of any race or sex, with histologic and/or radiologic proof of pancreatic adenocarcinoma (PDAC)
  • PDAC that is deemed resectable by the operating surgeon
  • Non-pregnant with an acceptable contraception method in premenopausal women
  • Signed, written informed consent

Exclusion Criteria:

  • Active bacterial, viral or fungal infection within 21 days of study entry
  • Women who are pregnant or breast feeding
  • Evidence of metastatic disease
  • Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin
  • Inability to take oral or nasojejunal nutritional supplements
  • Patients with immunodeficiency conditions
  • Patients on chronic steroid therapy
  • Patients with know sensitivity to arginine, omega-3 fatty acids or glutamine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838966


Contacts
Contact: Melissa Schlegel 502-629-3383 melissa.schlegel@louisville.edu
Contact: Mary Healey 502-629-3327 mary.healey@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Schlegel, CRC    502-629-3383    melissa.schlegel@louisville.edu   
Contact: Prejesh Philips, MD    502-629-2012    prejesh.philips@louisville.edu   
Principal Investigator: Prejesh Philips, MD         
Sponsors and Collaborators
University of Louisville
Nestlé
Investigators
Principal Investigator: Prejesh Philips, MD University of Louisville

Responsible Party: Prejesh Philips, Assistant Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02838966     History of Changes
Other Study ID Numbers: Immunonutrition PDAC #14-0779
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Prejesh Philips, University of Louisville:
immunomodulation
immunonutrition

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms