Pancreatic Enzyme Suppletion in Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Adenocarcinoma of the Pancreas Normal Pancreatic Exocrine Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard treatment

Treatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation.

Group Type ACTIVE_COMPARATOR

Timing of start treatment with pancreatic enzymes

Intervention Type OTHER

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).

Preventive treatment

Patients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea

Group Type ACTIVE_COMPARATOR

Timing of start treatment with pancreatic enzymes

Intervention Type OTHER

Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Panzytrat 'HL' Panzytrat 'HL'

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.