Pancreatic Enzyme Suppletion in Pancreatic Cancer

Phase 4

Withdrawn

• Conditions: Adenocarcinoma of the Pancreas; Normal Pancreatic Exocrine Function
• Interventions: Other: Timing of start treatment with pancreatic enzymes

• Registration Number: NCT01401387
• Lead Sponsor: Foundation for Liver Research

Brief 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.

Study Timeline

• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Study Start: 2011-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adenocarcinoma of the pancreas (histologically confirmed)
• Normal exocrine pancreatic function (Fecal Elastase test > 0.2 mg/g)
• Capable and willing to follow instructions given by the physician.

Exclusion Criteria

• Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
• < 18 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Timing of start treatment with pancreatic enzymes	Treatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation.
Preventive treatment	Timing of start treatment with pancreatic enzymes	Patients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea

Primary Outcome Measures

Name	Time	Method
To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss.	every month during 6 months after inclusion	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

Secondary Outcome Measures

Name	Time	Method
improvement of the nutritional status	every month during six months after inclusion	A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms
quality-of-life	on a monthly base during 6 months after inclusion	SF36 questionnaire

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands