What is the mechanism of action of this treatment?

The most common treatments for Pancreatic Adenocarcinoma include pancreatic enzyme supplementation, chemotherapy, and radiotherapy. Pancreatic enzyme supplementation, such as Pancreaze (pancrelipase), helps patients with exocrine pancreatic insufficiency by aiding digestion and nutrient absorption, which is vital for maintaining weight and overall health. Chemotherapy agents like gemcitabine and S-1 inhibit DNA synthesis in cancer cells, slowing tumor growth and spread. Radiotherapy uses high-energy radiation to target and destroy cancer cells. These treatments are crucial as they not only combat the tumor but also alleviate symptoms, thereby improving patient outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for pancreatic adenocarcinoma, such as gemcitabine plus nab-paclitaxel, are associated with side effects including neutropenia, fatigue, neuropathy, and diarrhea. Pancreatic enzyme supplementation with Pancreaze (pancrelipase) aims to aid digestion and nutrient absorption, and while specific side effects for this formulation are not detailed, enzyme supplements can sometimes cause gastrointestinal symptoms like abdominal pain, bloating, and diarrhea.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic adenocarcinoma, including enzyme replacement therapies like Pancreaze (pancrelipase), which helps patients with exocrine pancreatic insufficiency by aiding digestion and nutrient absorption. Other treatments for pancreatic adenocarcinoma include chemotherapy regimens such as gemcitabine and nab-paclitaxel, as well as FOLFIRINOX, which combines multiple chemotherapeutic agents. These treatments aim to manage symptoms, improve quality of life, and extend survival in patients with advanced pancreatic cancer.

What other types of research exist?

Promising alternatives to Pancreaze (pancrelipase) for pancreatic adenocarcinoma patients include fungal lipase, which has shown effectiveness in controlling steatorrhea with a significantly lower dosage compared to traditional pancreatin, and microbial enzyme preparations like Triase, which contains microbial lipase, protease, and alpha-amylase. Additionally, gene therapy approaches involving ectopic expression of pancreatic enzymes in the hepatobiliary tract are being explored as potential treatments for fat malabsorption due to pancreatic insufficiency.

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Pancreaze for Pancreatic Cancer (PANCAX-3 Trial)

Phase 2

Recruiting

Led By Andrew Hendifar, MD, MPH

Research Sponsored by Andrew Hendifar, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cachexia defined as at least 5% weight loss in the presence of chronic illness, within any 6-month period prior to screening OR as documented by the medical physician based on standard diagnosis of cachexia

Clinical diagnosis of exocrine pancreatic insufficiency

Must not have

Unable to swallow intact capsules

Dementia or altered mental status that would prohibit the understanding or rendering of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Pancreaze capsules in pancreatic cancer patients who have trouble digesting food. The medication provides missing enzymes to help them digest food better and improve their quality of life. Pancreatic enzyme supplementation is an important part of management for a number of gastrointestinal conditions.

Who is the study for?

This trial is for adults with pancreatic cancer who are experiencing weight loss and digestive issues due to the cancer affecting their pancreas' ability to aid in digestion. They should be relatively active, not have severe liver or heart conditions, and expect to live more than 3 months. Pregnant women or those unable to use birth control are excluded.

What is being tested?

The study tests whether Pancreaze (pancrelipase), a medication helping with digestion, can stabilize weight and improve life quality when added to standard care in patients whose pancreas doesn't produce enough digestive enzymes due to cancer.

What are the potential side effects?

Potential side effects of Pancreaze may include gastrointestinal symptoms like stomach pain, nausea, diarrhea; allergic reactions; and possibly colon strictures if used long-term at high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lost at least 5% of my weight in the last 6 months due to a chronic illness.

Select...

I have been diagnosed with a condition where my pancreas does not produce enough enzymes.

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My kidney function, measured by creatinine or its clearance, is within the required range.

Select...

I agree to use effective birth control or abstain from sex during and for 30 days after the study.

Select...

I am 18 years old or older.

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I am fully active or able to carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot swallow whole capsules.

Select...

I am able to understand and give consent for my treatment.

Select...

I have a chronic illness that affects how my body absorbs nutrients.

Select...

I have more than one type of cancer.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I am not pregnant or breastfeeding.

Select...

I am currently taking supplements that contain lipase, protease, and amylase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of completing pancreatic enzyme replacement therapy during the first 8 weeks of the study: daily compliance diary

Secondary study objectives

Change in microbiome from baseline

Mean change in average heart rate from baseline

Mean change in calories consumed from baseline through the end-of-study visit

+8 more

Side effects data

From 2022 Phase 4 trial • 36 Patients • NCT03924947

NAUSEA

100%

80%

60%

40%

20%

Study treatment Arm

Part 2 DB Creon AAPIS

Part 1 DB Creon

Part 2 DB Creon

Part 2 OL Creon Post-Randomization

Part 1 OL Creon Pre-Randomization

Part 1 DB Creon MP

Part 1 OL Creon Post-Randomization

Part 2 OL Creon Pre-Randomization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard of care treatment with Pancreaze (pancrelipase)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pancrelipase

2011

Completed Phase 4

~160

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pancreatic Adenocarcinoma include pancreatic enzyme supplementation, chemotherapy, and radiotherapy. Pancreatic enzyme supplementation, such as Pancreaze (pancrelipase), helps patients with exocrine pancreatic insufficiency by aiding digestion and nutrient absorption, which is vital for maintaining weight and overall health. Chemotherapy agents like gemcitabine and S-1 inhibit DNA synthesis in cancer cells, slowing tumor growth and spread. Radiotherapy uses high-energy radiation to target and destroy cancer cells. These treatments are crucial as they not only combat the tumor but also alleviate symptoms, thereby improving patient outcomes and quality of life.