Suspended

PANCAX-3Pancreaze Support for Weight Stability in Pancreatic Adenocarcinoma with Cachexia and Exocrine Pancreatic Insufficiency

Study Aim

This phase 2 study aims to evaluate the feasibility of completing Pancreatic Enzyme Replacement Therapy, specifically Pancreaze, for at least 50% of the required total lipase units, as recorded in a daily compliance diary, in individuals with Pancreatic Adenocarcinoma who are experiencing Cachexia and Exocrine Pancreatic Insufficiency.

What is being tested

Pancrelipase

Drug

Who is being recruted

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Phase 2

Interventional

Study Start: December 2020

See protocol details

Summary

Principal SponsorAndrew Hendifar, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 17, 2020

Actual date on which the first participant was enrolled.

This study focuses on individuals battling pancreatic adenocarcinoma, a type of pancreatic cancer, who also experience exocrine pancreatic insufficiency and weight loss. The main goal is to evaluate the impact of adding Pancreaze, a specific pancreatic-enzyme replacement therapy, to their standard care. This research aims to measure changes in weight stability, physical function, and quality of life. It's significant as it's the first study exploring this particular formulation of Pancreaze in conjunction with standard care for advanced pancreatic cancer patients. During the study, 40 patients will receive Pancreaze in doses of 84,000-lipase units for main meals and 42,000-lipase units for snacks. The primary outcome is to assess the feasibility of completing this therapy over the first 8 weeks. Participants will keep a daily compliance diary to track their adherence to the therapy, with at least 50% of the needed total lipase units considered as good compliance.

Official TitlePancreatic-enzyme Replacement Therapy With Pancreaze (Pancrelipase) Delayed-release in Addition to Standard of Care for Borderline Resectable, Locally Advanced, and Advanced Pancreatic Adenocarcinoma Patients (PANCAX-3) With Cachexia and Exocrine Pancreatic Insufficiency

NCT04098237

Principal SponsorAndrew Hendifar, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Age ≥ 18 years.

Clinical diagnosis of exocrine pancreatic insufficiency

Life expectancy of greater than 3 months, in the opinion of the investigator.

Patients must have normal organ and marrow function as defined below: Absolute Neutrophil Count (ANC) ≥ 500/mcL, Platelets ≥ 50,000/mcL, Total bilirubin ≤ 5X upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) ≤ 5 X ULN, Creatinine OR creatinine clearance ≤ 3 times the upper limit of normal OR ≥ 30 mL/min/1.73 m² for patients with creatinine levels above normal. Note: Patients with biliary stents are eligible provided that all other inclusion criteria are met.

6 exclusion criteria prevent from participating

Unable to swallow intact capsules

Coexistent other primary malignancy

Known allergy to any of the active ingredients in pancreatic enzyme supplementation

Concurrent use of pancreatic enzyme supplementation or over the counter supplements which contain lipase, protease, and amylase as active ingredients

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cedars-Sinai Medical Center

Los Angeles, United StatesOpen Cedars-Sinai Medical Center in Google Maps

SuspendedOne Study Center