NCT02838966

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2019

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

5.3 years

First QC Date

November 18, 2015

Last Update Submit

July 10, 2021

Conditions

Pancreatic Adenocarcinoma

Keywords

immunomodulationimmunonutrition

Outcome Measures

Primary Outcomes (2)

  • Change in levels of circulating Myeloid derived suppressor cells

    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)

    Within 2 weeks of study intervention (at pre-anesthesia visit) to surgery. Study intervention to start 5 days before surgery

  • Overall morbidity rate.

    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)

    30 day morbidity from surgery

Secondary Outcomes (3)

  • Tolerability of Supplement

    90 days from surgery

  • Hospital length of stay

    90 days from surgery

  • Change in serum arginine levels

    Within 2 weeks of study intervention (at pre-anesthesia visit) to surgery. Study intervention to start 5 days before surgery

Study Arms (4)

Nestle IMPACT Advanced Recovery 1

ACTIVE COMPARATOR

1 can per day for 5 days prior to surgery

Dietary Supplement: Nestle IMPACT Advanced Recovery

Nestle IMPACT Advanced Recovery 2

ACTIVE COMPARATOR

2 cans per day for 5 days prior to surgery

Dietary Supplement: Nestle IMPACT Advanced Recovery

Nestle IMPACT Advanced Recovery 3

ACTIVE COMPARATOR

3 cans per day for 5 days prior to surgery

Dietary Supplement: Nestle IMPACT Advanced Recovery

Nestle Boost High Protein Drink - Control Arm

ACTIVE COMPARATOR

4 cans per day for 5 days prior to surgery

Dietary Supplement: Nestle Boost High Protein Drink

Interventions

Nestle IMPACT Advanced RecoveryDIETARY_SUPPLEMENT
Nestle IMPACT Advanced Recovery 1Nestle IMPACT Advanced Recovery 2Nestle IMPACT Advanced Recovery 3
Nestle Boost High Protein DrinkDIETARY_SUPPLEMENT
Nestle Boost High Protein Drink - Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Prejesh Philips, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2015

First Posted

July 20, 2016

Study Start

August 1, 2014

Primary Completion

November 11, 2019

Study Completion

November 11, 2019

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

US(1)