Whipple Protein Study (WPS)

Thomas Jefferson University

Status: Completed

Conditions: Malnutrition; Pancreatic Cancer

Treatments: Dietary Supplement: Ensure Max Protein

Study type: Interventional

Funder types: Other

Identifiers

NCT04306874

19D.669

JT 14375 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• Patients with ongoing eating disorder or condition precluding oral intake
• Patients who are scheduled for pancreaticoduodenectomy but are unable to receive this surgery

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

High Protein Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ensure Max Protein

Control

No Intervention group

Description:

No intervention on diet; routine dietary practice