Malnutrition, Pancreatic Cancer
Conditions
Keywords
pancreaticoduodenectomy, surgery, nutrition, protein
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.
Interventions
DIETARY_SUPPLEMENTEnsure Max Protein
Liquid shake with 30 g protein per serving
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 30 days | All complications within 30 days of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed