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Study on Pancreas Powder for Digestive Issues in Patients with Unresectable Pancreatic Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called pancreatic exocrine insufficiency in patients who have unresectable pancreatic cancer. This condition occurs when the pancreas does not produce enough enzymes to help digest food, leading to problems with nutrition and weight loss. The treatment being tested in this study is called pancreatic enzyme replacement therapy (PERT), which involves taking a medication known as Kreon 35,000 U. This medication is designed to help replace the enzymes that the pancreas is not producing, potentially improving digestion and nutritional status.

The purpose of the study is to evaluate whether PERT can help patients with pancreatic cancer gain weight and improve their overall health and quality of life. Participants in the study will be randomly assigned to receive either the PERT treatment or a placebo. The study will last for six months, during which time participants will have regular check-ups to monitor their weight, nutritional status, and overall health. The study aims to see if PERT can lead to weight gain, better nutrition, and improved tolerance to chemotherapy, which may ultimately enhance the quality of life and survival for these patients.

Throughout the study, various health markers will be monitored, including changes in blood components like haemoglobin and lymphocytes, as well as nutritional markers such as albumin and cholesterol. The study will also assess changes in symptoms related to digestion, such as diarrhea and abdominal discomfort, and evaluate the participants' quality of life using a specific questionnaire. The results will help determine if PERT is beneficial for patients with pancreatic cancer who are experiencing pancreatic exocrine insufficiency.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the trial's purpose and procedures. Participants will be required to sign an informed consent form, confirming their understanding and willingness to participate.
Step 2
Initial assessment
Participants will undergo an initial assessment to establish baseline measurements. This includes recording body weight and evaluating nutritional status. Blood samples may be taken to measure various health markers such as haemoglobin and cholesterol levels.
Step 3
Medication administration
Participants will begin taking the medication Kreon 35 000 U, which contains pancreas powder. This medication is taken orally in the form of gastro-resistant capsules. The dosage and frequency will be determined by the study team based on individual needs.
Step 4
Ongoing monitoring
Throughout the study, participants will have regular check-ups to monitor their health and response to the medication. This includes tracking changes in body weight, nutritional markers, and quality of life. Participants may also be asked about any symptoms they experience, such as digestive issues.
Step 5
Mid-study evaluation
At the three-month mark, participants will undergo a mid-study evaluation. This involves reassessing body weight, nutritional status, and other health indicators. The study team will review the participant's progress and make any necessary adjustments to the treatment plan.
Step 6
Final assessment
At the end of the six-month study period, participants will have a final assessment. This includes a comprehensive evaluation of body weight, nutritional markers, and overall health. The study team will analyze the data to determine the impact of the treatment.

Who can join the trial?

7 criteria

Patients must be older than 18 years and can be of any gender.
Must have a diagnosis of unresectable pancreatic cancer, which means the cancer cannot be removed by surgery. It should be either locally advanced or has spread to other parts of the body (metastatic).
The tumor must be located in the head of the pancreas.
There should be a dilated main pancreatic duct, which is a widened duct in the pancreas, confirmed by imaging tests like a CT scan, MRI, or EUS (Endoscopic Ultrasound).
Must have experienced significant weight loss of 5% or more of their usual body weight at the time of screening.
Should have a life expectancy of at least six months at the time of screening.
Must provide a signed informed consent to participate in the study, which means they agree to join the study after being informed about all aspects of it.

Who cannot join the trial?

4 criteria

Patients with conditions other than pancreatic exocrine insufficiency cannot participate. This means if you have a different medical condition, you may not be eligible.
Patients who have had surgery to remove their pancreatic cancer are not eligible. This study is for those with unresectable pancreatic cancer, meaning the cancer cannot be removed by surgery.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population are not eligible. This includes groups that may need special protection or care.

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Verified sites

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Hospital Universitario De Navarra
Pamplona, Spain
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San Raffaele Scientific Institute
Milan, Italy
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Universidade De Santiago De Compostela
Santiago De Compostela, Spain

Trial locations

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Investigated drugs

Pancreatic Enzyme Replacement Therapy (PERT) is a treatment used to help people who have trouble digesting food because their pancreas is not working properly. In this trial, PERT is being tested on patients with pancreatic cancer that cannot be removed by surgery. The therapy involves taking pills that contain enzymes similar to those made by a healthy pancreas. These enzymes help break down food in the stomach, allowing the body to absorb nutrients better. The goal of using PERT in this trial is to help patients gain weight, improve their nutrition, and enhance their overall quality of life. By doing so, it may also help them tolerate cancer treatments better and potentially improve their chances of survival.

Pancreas Powder

What is already known about the treatment

Pancreatic Enzyme Replacement Therapy (PERT) – This medication is administered orally in the form of capsules or tablets and is used to help people with pancreatic exocrine insufficiency, a condition where the pancreas does not produce enough enzymes to digest food properly. PERT is currently being studied in clinical trials for its potential benefits in patients with unresectable pancreatic cancer, aiming to improve their nutritional status and quality of life. The main therapeutic indication for PERT is to aid digestion by providing the necessary enzymes that the pancreas is unable to produce. At the molecular level, PERT works by breaking down fats, proteins, and carbohydrates in the food, allowing the body to absorb nutrients more effectively. It is classified pharmacologically as a digestive enzyme supplement.

Investigated diseases

Pancreatic exocrine insufficiency – Pancreatic exocrine insufficiency is a condition where the pancreas does not produce enough enzymes to properly digest food. This leads to malabsorption, where nutrients from food are not absorbed effectively by the body. As the condition progresses, individuals may experience symptoms such as diarrhea, weight loss, and abdominal discomfort. Over time, the lack of proper digestion can lead to deficiencies in essential nutrients and vitamins. The condition is often associated with other diseases, such as chronic pancreatitis or pancreatic cancer. Management focuses on addressing the symptoms and improving nutrient absorption.