Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

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.

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

- 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