Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Neoplasms, Pancreatic Cancer, Cachexia, Weight Loss

Intervention / Treatment
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* Other: Tube feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy Cachexia defined as greater than 5% unexplained weight loss within 6 months prior to screening visit or consultation with medical oncologist Candidate for enteral feeding with Peptamen, a peptide based formula. Must have jejunal or gastrojejunal tube either previously placed or at least prior to Day 1 of study Age ≥ 18 years. ECOG performance status 0-2 Greater than or equal to 3 month life expectancy Ability to understand and the willingness to sign a written informed consent May have received prior anti-cancer treatment, complete or partial resection of primary tumor Patients must be ambulatory and have access to a smart phone to participate in the activity tracker sub-study Exclusion Criteria: Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Malignant ascites requiring paracenteses Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Bowel obstruction, partial or total Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tube feeding with peptide-base formula<br>The peptide-based formula (Peptamen) will be administered through a gastrojejunal or jejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered for three 28-day cycles. | Other: Tube feeding<br>* 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.<br>* Other names: Gastrojejunal tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lean body mass | Measured by Dexa Scan | Change from baseline at 3 months | 
| Performance Status (ECOG) |  | Change from baseline at 3 months | 
| Quality of Life (EORTC QLQ-C30) |  | Change from baseline at 3 months | 
| Response to nutritional management | Assessment based on tumor biomarkers during enteral feeding period | Change from baseline at 3 months | 
| Food intake assessment by 24-hour recall |  | Change from baseline at 3 months | 
| Smell and taste alteration by questionnaire |  | Change from baseline at 3 months | 
| Muscle strength using hand grip strength dynamometer |  | Change from baseline at 3 months | 
| Survival |  | 3 years | 
| Activity - steps taken | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months | 
| Activity - number of stairs | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months | 
| Activity - sleep duration and interruptions | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months | 
| Activity - heart rate | As tracked by Fitbit Charge HR biosensor | Change from baseline at 3 months | 
| Changes in microbiome analysis | As measured by stool sample microbiome analysis | Change from baseline at 3 months |