WPS: Whipple Protein Study

Sponsor

Thomas Jefferson University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04306874

Collaborator

(none)

172

Enrollment

Arms

24.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Malnutrition	Dietary Supplement: Ensure Max Protein	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placeboParallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy

Anticipated Study Start Date :

Mar 15, 2020

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Protein Supplement 60 g total protein per day, administered via twice daily ensure max protein shakes	Dietary Supplement: Ensure Max Protein Liquid shake with 30 g protein per serving
No Intervention: Control No intervention on diet; routine dietary practice

Arm

Intervention/Treatment

Experimental: High Protein Supplement

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

Dietary Supplement: Ensure Max Protein

Liquid shake with 30 g protein per serving

No Intervention: Control

No intervention on diet; routine dietary practice

Outcome Measures

Primary Outcome Measures

Complications [30 days]
All complications within 30 days of surgery

Secondary Outcome Measures

Overall Survival [6 months]
Overall survival time since surgery
Prealbumin level [30 days]
Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator: Harish Lavu, MD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT04306874

Other Study ID Numbers:

19D.669

First Posted:

Mar 13, 2020

Last Update Posted:

Mar 13, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Jefferson University

pancreaticoduodenectomy

surgery

nutrition

protein

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Mar 13, 2020