Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

Pancreatic Cancer Clinical Trial

— PanCax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400398
• Other study ID #: IIT2014-03-Hendifar-PNCX1
• Status: Completed
• Start date: April 27, 2015
• Est. completion date: May 15, 2020

Study information

• Verified date: August 2020
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Cachexia
• Pancreatic Cancer
• Pancreatic Neoplasms
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Hendifar, MD

Country where clinical trial is conducted

United States, 

Outcome

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