Pancreatic Enzyme Replacement Therapy in Pancreatic Cancer - A Randomized Controlled Trial

This research project is aimed at people who have known cancer of the pancreas, who may have symptoms or signs of pancreatic exocrine insufficiency (PEI). Pancreatic exocrine insufficiency (PEI) occurs when diseases of the pancreas prevent it from functioning properly. In the healthy state the pancreas releases substances in into the intestinal system to breakdown ingested fats. In patients with cancer of the pancreas this process can be impaired due to blockage of the pancreatic duct or due to poor function of the pancreas. This means that some patients with pancreatic cancer cannot breakdown fats and so they cannot absorb fats from their food. This results in: - Weight loss - or inability to gain weight - Non-absorption of essential vitamins found in fats (for example vitamin A, D, E and K) - Unpleasant fatty diarrhoea which is frequent, foul smelling and difficult to flush Pancreatic enzyme replacement therapy (or PERT) is a medication that these patients can take which replaces the most important of the body’s natural pancreatic enzymes and therefore allows better breakdown and absorption of fats. This helps patients with pancreatic cancer to maintain a healthy weight, and have reduction in the unpleasant side effects of frequent diarrhoea. This is important for this patient group as it reduces time spent in hospital towards the end of their life due to complications arising from low weight and malnutrition and improves their quality of life. Good nutrition is also important if patients are going to be able to tolerate other treatment, for instance chemotherapy. This research project will involve patients with known cancer of the pancreas. They will be randomly allocated into two groups. Each group will be given a supply of tablets, to be taken at home for a period of 4 weeks. Neither group will know what medication the tablets contain. Group A will receive PERT tablets, and group B will receive a placebo tablet (meaning a completely harmless tablet with no medication in it). The patients will be required to keep a bowel chart whilst taking the medication. Patients will be able to contact a dietician for support if they require it throughout the 4 week period. Both at the start and at the end of the 4 week study period, patients will be weighed, and they will also have their stool tested. The stool testing requires two samples only (i.e. One at the start and one at the end of the study period), and can be done at a time which is convenient for the patient. Patients will also complete a questionnaire relating to their quality of life, both before and after the 4-week medication period. PERT medication is already used to help alleviate some of the unpleasant symptoms associated with pancreatic cancer, however not all doctors prescribe it routinely. The results of this study may support or refute its use in patients with pancreatic cancer, and will therefore give doctors good evidence for prescribing or not prescribing PERT to help their patients with this condition.