Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients (PanCax)

August 9, 2020 updated by: Andrew Hendifar, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pancreatic cancer patients with cachexia receiving enteral feedings by way of gastrojejunal or jejunal tube.

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.
Other Names:
  • Enteral feeding
  • Jejunal tube
  • Gastrojejunal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: Change from baseline at 3 months
Change from baseline at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Andrew Hendifar, MD

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 Major Dates

Study Start (Actual)

April 27, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 9, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2014-03-Hendifar-PNCX1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Neoplasms

Clinical Trials on Tube feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe