Pancreatic Enzyme Suppletion in Pancreatic Cancer (EPC)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Adenocarcinoma of the Pancreas; Normal Pancreatic Exocrine Function
• Intervention / Treatment: Other: Timing of start treatment with pancreatic enzymes; Other: Timing of start treatment with pancreatic enzymes

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3000 WB
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard treatment; Treatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation.	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 Names: Panzytrat 'HL'; 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.; Other Names: Panzytrat 'HL'
Active Comparator: Preventive treatment; Patients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea	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 Names: Panzytrat 'HL'; 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.; Other Names: Panzytrat 'HL'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of the nutritional status	Nutritional deficiencies, 1 sample of blood will be drawn (3 times 8ml of blood): Glucose, HbA1c (glycol Hb); Magnesium, phosphate, ferritin; Hb; albumin; total protein; calcium; folic acid; vitamin A, E, B12; 1,25-di-OH-Vitamine D; 25-hydroxy vitamin D (25-OH-vitamin D)	every three months
quality-of-life	SF36 questionnaire	on a monthly base during 6 months after inclusion
improvement of the nutritional status	A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms	every month during six months after inclusion

Collaborators and Investigators

• Sponsor: Foundation for Liver Research
• Investigators: Principal Investigator: Marco Bruno, MD, PhD, Erasmus Medical Center

Publications and helpful links

Helpful Links

• Bruno MJ, Haverkort EB, Tijssen GP, Tytgat GN, van Leeuwen DJ. Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region. Gut. 1998 Jan;42(1):92-6.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: EPC 11-01; 2011-003373-28 (EudraCT Number)