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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

November 18, 2015
July 20, 2016
May 2, 2017
August 2014
March 2019   (Final data collection date for primary outcome measure)
  • 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)
  • 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)
Same as current
Complete list of historical versions of study NCT02838966 on ClinicalTrials.gov Archive Site
  • Tolerability [ Time Frame: 90 days from surgery ]
    Tolerability of supplement: as defined as ability to complete the nutritional intervention using a patient log.
  • Hospital length of stay [ Time Frame: 90 days from surgery ]
    Length of hospital stay (in days)
  • 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
Same as current
Not Provided
Not Provided
 
Preoperative Nutrition With Immune Enhancing Nutritional Supplement (Immunomodulation)
Preoperative Nutritional Supplementation With Immunomodulators for Patients With Resectable Pancreatic Adenocarcinoma: Efficacy and Optimal Dose
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.

Study Objectives: The primary objective 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.

Primary Endpoints:

The primary endpoints will be effect on immunological profile (circulating Myeloid derived suppressor cells, circulating B cells, NK cells, CD4 and CD8 cells), serum arginine levels, immunological milieu of the tumor (tumor infiltrating lymphocytes), overall morbidity rate and infectious complication rates.

Secondary Endpoints:

  • Monitor Safety and Tolerability
  • Hospital Length of Stay
  • Readmission rate
  • One-year event free survival
  • Effect on nutritional parameters (serum total protein, prealbumin, albumin and transferrin)
  • Effect on acute phase reactants (CRP, IL6, TNF alpha)

Study Design: This is a 1:1:1:1 four-arm single center prospective randomized feasibility study to compare preoperative nutritional supplementation with an enhanced formula containing immune-modulating agents (IMPACT AR) for 5 days with 1,2 or 3 cans versus 5 days of 3 cans of comparable iso-caloric iso-nitrogenous supplementation (Boost) for patients with resectable pancreatic adenocarcinoma.

Number of Patients 20 (5 in each arm) Eligibility Criteria: Patients over 18 years of age, who have histologic and/or radiologic evidence of pancreatic adenocarcinoma in the head of the pancreas, who have been deemed resectable, and who are able to give informed consent, will be eligible Exclusion criteria would include Active uncontrolled bacterial, viral or fungal infection within 21 days of study entry OR Inability to take oral, nasojejunal or jejunostomy tube nutritional supplements OR patients on chronic steroid therapy (i.e. greater than 3 months)

Nutritional Supplement interventions:

Patients randomized to the TEST intervention will receive Impact Advanced Recovery™ formula, which is a commercially available oral nutrition supplement drink that is supplied in 237mL containers. Each serving provides 1.4 kcal/mL (340 kcal/serving) of which 22% of the kcal are derived from protein (18.1 gm protein/serving), in addition to their regular diet. Patients randomized to CONTROL Boost® High Protein Drink will consume their regular diet and 4 cans of Boost per day for 5 days preoperatively (to maintain equivalent supplementation in terms of calories and protein with the group receiving the highest dose of Impact AR).

Study procedure:

Screening/baseline assessments will performed prior to the first treatment within approximately four weeks of the treatment and will include a detailed medical history and physical examination,standard of Care Laboratory tests (CBC, CMP), tumor markers: as indicated: CEA and CA19-9; and coagulation (baseline and as clinically indicated): INR, PTT, PT. Imaging to confirm respectability would include a high quality tri-phasic CT scan with 0.7mm cuts or Dynamic MRI with contrast to confirm the absence of metastatic disease Study specific tests include pre-treatment and post treatment (Office visit/ pre-anesthesia visit, Morning of surgery, postop day 5)

  • Nutritional parameters and acute phase reactants: serum prealbumin, albumin, transferrin, CRP, IL6, TNF alpha
  • Serum arginine,
  • MSDC (myeloid derived suppressor cell) assay of fresh blood and Arginase I expression Study procedure at the time of surgery: Semi-quantitative assay of Tumor infiltrating lymphocytes from tissue block of tumor obtained at time of surgery. Tumor tissue will also be banked for post hoc tests if needed.

During follow up visits history and physical examination, performance Status evaluation and Standard of care Laboratory Tests (CBC, CMP, and Tumor Marker Assessment as clinically indicated per the discretion of the investigator would be done approximately every three months). Imaging during follow up include a CT/MRI for disease status (approximately every three months during follow-up) Adverse Event Monitoring and Concomitant Medication monitoring will be done out to 90 days

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Pancreatic Adenocarcinoma
  • Dietary Supplement: Nestle IMPACT Advanced Recovery
  • Dietary Supplement: Nestle Boost High Protein Drink
  • Active Comparator: Nestle IMPACT Advanced Recovery 1
    1 can per day for 5 days prior to surgery
    Intervention: Dietary Supplement: Nestle IMPACT Advanced Recovery
  • Active Comparator: Nestle IMPACT Advanced Recovery 2
    2 cans per day for 5 days prior to surgery
    Intervention: Dietary Supplement: Nestle IMPACT Advanced Recovery
  • Active Comparator: Nestle IMPACT Advanced Recovery 3
    3 cans per day for 5 days prior to surgery
    Intervention: 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
    Intervention: Dietary Supplement: Nestle Boost High Protein Drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
August 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Melissa Schlegel 502-629-3383 melissa.schlegel@louisville.edu
Contact: Mary Healey 502-629-3327 mary.healey@louisville.edu
United States
 
 
NCT02838966
Immunonutrition PDAC #14-0779
No
Not Provided
Not Provided
Prejesh Philips, University of Louisville
University of Louisville
Nestlé
Principal Investigator: Prejesh Philips, MD University of Louisville
University of Louisville
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP