Evaluating Weight Stability of Pancreatic Cancer Cachexia Patients

NCT02400398 | Completed

• 1 other identifier: IIT2014-03-Hendifar-PNCX1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms; Pancreatic Cancer; Cachexia; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight

  Change from baseline at 3 months

Secondary Outcomes (13)

• Change in lean body mass

  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

  Change from baseline at 3 months

• Food intake assessment by 24-hour recall

  Change from baseline at 3 months

Study Arms (1)

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

Interventions

Tube feeding OTHER

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.

Also known as: Enteral feeding, Jejunal tube, Gastrojejunal tube

Tube feeding with peptide-base formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Hendifar, MD: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia; Weight Loss

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Andrew Hendifar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: March 27, 2015
• Study Start: April 27, 2015
• Primary Completion: March 1, 2019
• Study Completion: May 15, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)