Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy
Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side
effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer,
additional weight loss and malnutrition may be due to the development of exocrine pancreatic
insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked,
because the focus of treatment is directed at possible surgery or chemotherapy and its
potential side effects. Although studies have proven that pancreatic enzymes may prevent or
decrease weight loss, they are seldom being prescribed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss.
Percentage of change in body weight ((index weight - monthly weight)/ index weight) x100% during the 6 months of follow-up. This will be measured on a monthly basis and measured by area under the ROC (Receiver Operating Characteristic) curve
every month during 6 months after inclusion
Marco Bruno, MD, PhD
Erasmus Medical Center
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)