NCT01401387

Pancreatic Enzyme Suppletion in Pancreatic Cancer

Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

Detailed description

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.

Conditions

• Adenocarcinoma of the Pancreas
• Normal Pancreatic Exocrine Function

Interventions

Type	Name	Description
OTHER	Timing of start treatment with pancreatic enzymes	Patients who are randomised to standard treatment will start taking pancreatic enzymes only if they develop steatorrhea-related symptoms in combination with at least a 10% decrease in body weight (index weight at the time of randomisation).
OTHER	Timing of start treatment with pancreatic enzymes	Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-07-25
• Last updated: 2013-02-22

Locations

1 site across 1 country: Netherlands