Evaluating Weight Stability Of Pancreatic Cancer Cachexia Patients

Study Overview

Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

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.

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.

Pancreatic Neoplasms
Pancreatic Cancer
Cachexia
Weight Loss

OTHER: Tube feeding

IIT2014-03-Hendifar-PNCX1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-08-09
First Submitted that Met QC Criteria 2015-03-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-08-11
First Posted (ACTUAL) 2015-03-27	Results First Posted N/A	Last Verified 2020-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Tube feeding with peptide-base formula 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 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.

Participant Group/Arm

Intervention/Treatment

: Tube feeding with peptide-base formula

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

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.

Primary Outcome Measures	Measure Description	Time Frame
Weight		Change from baseline at 3 months

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Andrew Hendifar, MD, Cedars-Sinai Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record