In short
In recent clinical trials, researchers are investigating the potential benefits of Rizolipase, a pancreatic enzyme, for patients who have undergone gastrectomy (removal of part or all of the stomach). This study aims to determine if enzyme supplementation, including Rizolipase, can improve the quality of life for these patients. The trial focuses on evaluating the effects of a combination of enzymes, including amylase, protease, and rizolipase, administered as a capsule called Nortase®.
At a glance
- Trial Name
- The Pancreatic Enzymes after Gastrectomy Trial
- Main Objective
- To determine if enzyme supplementation improves quality of life after gastrectomy
- Participants
- Patients aged 18 or older who have undergone total or partial gastrectomy
- Drug Tested
- Nortase® (containing amylase, protease, and rizolipase)
- Treatment Duration
- Up to 6 months
- Primary Endpoint
- Disease-specific quality of life at 6 months (EORTC-QLQ-C30 physical sub-score)
- Dosage
- Maximum daily dose: 15 units; Maximum total dose: 2700 units
- Administration Route
- Oral
What is RIZOLIPASE?
RIZOLIPASE is an active substance that belongs to a group of medications known as pancreatic enzymes. It is one of the key components in a medication called Nortase®, which also contains two other enzymes: amylase and protease. These enzymes work together to help digest food in patients who have undergone a gastrectomy, which is the surgical removal of all or part of the stomach.
Medical Conditions Treated
RIZOLIPASE, as part of the Nortase® medication, is primarily used to treat patients who have undergone a gastrectomy (total or partial removal of the stomach). After this surgery, patients often experience difficulties in digesting food properly, which can lead to various nutritional problems and a decreased quality of life. The enzyme combination in Nortase®, including RIZOLIPASE, aims to improve digestion and overall well-being in these patients.
How RIZOLIPASE Works
RIZOLIPASE is a type of lipase, which is an enzyme that helps break down fats in the food we eat. When combined with amylase (which breaks down carbohydrates) and protease (which breaks down proteins), RIZOLIPASE helps to compensate for the reduced digestive function in patients who have had their stomach removed or partially removed. By taking these enzymes with meals, patients may be able to digest their food more effectively, potentially leading to better nutrition and improved quality of life.
Current Clinical Trial
RIZOLIPASE is currently being studied in a clinical trial called "The Pancreatic Enzymes after Gastrectomy Trial". This trial aims to investigate whether taking enzyme supplements (including RIZOLIPASE) with every meal after gastrectomy can improve the quality of life for patients six months after their surgery.
Eligibility for the Trial
To participate in this clinical trial, patients must meet certain criteria:
Inclusion Criteria:
- Have undergone a gastrectomy (total or partial)
- Be 18 years of age or older
Exclusion Criteria:
- Already have an indication for pancreas enzyme therapy
- Have had a gastrectomy with palliative intention (meaning the surgery was done to relieve symptoms rather than to cure)
- Have Stage IV gastric cancer (advanced stage cancer that has spread to distant parts of the body)
- Have malnutrition from other causes
- Have a life expectancy of less than 12 months
- Have known lactose intolerance or hereditary galactose intolerance
- Are taking alpha-glucosidase inhibitors (a type of medication used to treat diabetes)
- Have acute pancreatitis or an acute episode of chronic pancreatitis (inflammation of the pancreas)
- Have a known hypersensitivity (allergy) to molds or any other ingredient in Nortase®
How RIZOLIPASE is Administered
RIZOLIPASE, as part of Nortase®, is taken orally in the form of a hard capsule. In the clinical trial, patients are instructed to take the enzyme supplement with every meal. The maximum daily dose mentioned in the trial is 15 capsules, with a total maximum dose of 2700 capsules over a 6-month period.
Potential Benefits
The main goal of using RIZOLIPASE and other pancreatic enzymes after gastrectomy is to improve the patient's disease-specific quality of life. This is being measured in the clinical trial using a standardized questionnaire (EORTC-QLQ-C30) that assesses various aspects of a patient's physical well-being. By potentially improving digestion, these enzymes may help patients better absorb nutrients from their food, potentially leading to improved overall health and well-being.
Precautions and Contraindications
While RIZOLIPASE and other pancreatic enzymes can be beneficial for many patients after gastrectomy, there are some situations where they should not be used:
- If you have a known allergy to molds or any ingredients in Nortase®
- If you have acute pancreatitis or an acute episode of chronic pancreatitis
- If you have lactose intolerance or hereditary galactose intolerance
- If you are taking alpha-glucosidase inhibitors
Always consult with your healthcare provider before starting any new medication, including pancreatic enzyme supplements like those containing RIZOLIPASE.