Pancreatic Enzyme Suppletion in Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adenocarcinoma of the Pancreas, Normal Pancreatic Exocrine Function

Intervention / Treatment
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* Other: Timing of start treatment with pancreatic enzymes
* Other: Timing of start treatment with pancreatic enzymes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>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<br>* 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).<br>* Other names: Panzytrat 'HL';|
| Active Comparator: Preventive treatment<br>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<br>* Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.<br>* Other names: Panzytrat 'HL';|

What is the study measuring?
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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 |