NCT02400398

Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Andrew Hendifar, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy. This study will observe a standard of care intervention (tube feeding) for potential benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the duration of the protocol.

Detailed description

In this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. We plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. Our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. Furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.

Conditions

• Pancreatic Neoplasms
• Pancreatic Cancer
• Cachexia
• Weight Loss

Interventions

Type	Name	Description
OTHER	Tube feeding	Jejunal or gastrojejunal tube feeds will be given as continuous feeds via pump with Peptamen (medical food), at the patient's home, for the duration of the protocol and as directed by the nutritionist.

Timeline

• Start date: 2015-04-27
• Primary completion: 2019-03-01
• Completion: 2020-05-15
• First posted: 2015-03-27
• Last updated: 2020-08-11

Locations

1 site across 1 country: United States