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Pancreatic Enzyme Suppletion in Pancreatic Cancer (EPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401387
Recruitment Status : Withdrawn (study never started)
First Posted : July 25, 2011
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Normal Pancreatic Exocrine Function Other: Timing of start treatment with pancreatic enzymes Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy
Study Start Date : October 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

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 Name: 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 allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.
Other Name: Panzytrat 'HL'

Primary Outcome Measures :
  1. To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss. [ Time Frame: 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 :
  1. improvement of the nutritional status [ Time Frame: every three months ]

    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)

  2. quality-of-life [ Time Frame: on a monthly base during 6 months after inclusion ]
    SF36 questionnaire

  3. improvement of the nutritional status [ Time Frame: every month during six months after inclusion ]
    A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01401387

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Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3000 WB
Sponsors and Collaborators
Foundation for Liver Research
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Principal Investigator: Marco Bruno, MD, PhD Erasmus Medical Center
Additional Information:
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Responsible Party: Foundation for Liver Research Identifier: NCT01401387    
Other Study ID Numbers: EPC 11-01
2011-003373-28 ( EudraCT Number )
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Gastrointestinal Agents