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Whipple Protein Study (WPS)

Primary Purpose

Pancreatic Cancer, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure Max Protein
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring pancreaticoduodenectomy, surgery, nutrition, protein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing pancreaticoduodenectomy
  • Patients aged 18 years and older
  • Patients able to provide written informed consent
  • Patients able to understand and comply with study guidelines
  • Patients able to tolerate oral intake
  • Patients who are malnourished or at risk of malnutrition as defined by a score less than 12 on the Mini-Nutritional Assessment

Exclusion Criteria:

  • Patients with a milk protein allergy
  • Patients with a vegan diet
  • Patients dependent on artificial enteral feeding
  • Patients with end-stage renal disease undergoing dialysis
  • Patients who are pregnant

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High Protein Supplement

Control

Arm Description

60 g total protein per day, administered via twice daily ensure max protein shakes

No intervention on diet; routine dietary practice

Outcomes

Primary Outcome Measures

Complications
All complications within 30 days of surgery

Secondary Outcome Measures

Overall Survival
Overall survival time since surgery
Prealbumin level
Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.

Full Information

First Posted
December 6, 2019
Last Updated
March 2, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04306874
Brief Title
Whipple Protein Study
Acronym
WPS
Official Title
High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery
Detailed Description
Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Malnutrition
Keywords
pancreaticoduodenectomy, surgery, nutrition, protein

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Protein Supplement
Arm Type
Experimental
Arm Description
60 g total protein per day, administered via twice daily ensure max protein shakes
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention on diet; routine dietary practice
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Max Protein
Intervention Description
Liquid shake with 30 g protein per serving
Primary Outcome Measure Information:
Title
Complications
Description
All complications within 30 days of surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival time since surgery
Time Frame
6 months
Title
Prealbumin level
Description
Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing pancreaticoduodenectomy Patients aged 18 years and older Patients able to provide written informed consent Patients able to understand and comply with study guidelines Patients able to tolerate oral intake Patients who are malnourished or at risk of malnutrition as defined by a score less than 12 on the Mini-Nutritional Assessment Exclusion Criteria: Patients with a milk protein allergy Patients with a vegan diet Patients dependent on artificial enteral feeding Patients with end-stage renal disease undergoing dialysis Patients who are pregnant Patients with ongoing eating disorder or condition precluding oral intake Patients who are scheduled for pancreaticoduodenectomy but are unable to receive this surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harish Lavu, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Whipple Protein Study

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