Clinical trial NCT02400398: Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients
Official title: A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Pancreatic Cancer
Cachexia
Weight Loss
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients with cachexia receiving enteral feedings by way of gastrojejunal or jejunal tube.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Change in lean body mass
timeFrame: Change from baseline at 3 months
measure: Performance Status (ECOG)
timeFrame: Change from baseline at 3 months
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: Change from baseline at 3 months
measure: Response to nutritional management
timeFrame: Change from baseline at 3 months
measure: Food intake assessment by 24-hour recall
timeFrame: Change from baseline at 3 months
measure: Smell and taste alteration by questionnaire
timeFrame: Change from baseline at 3 months
measure: Muscle strength using hand grip strength dynamometer
timeFrame: Change from baseline at 3 months
measure: Survival
timeFrame: 3 years
measure: Activity - steps taken
timeFrame: Change from baseline at 3 months
measure: Activity - number of stairs
timeFrame: Change from baseline at 3 months
measure: Activity - sleep duration and interruptions
timeFrame: Change from baseline at 3 months
measure: Activity - heart rate
timeFrame: Change from baseline at 3 months
measure: Changes in microbiome analysis
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Andrew Hendifar, MD
role: PRINCIPAL_INVESTIGATOR
References: