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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003373-28 | EudraCT Number |
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study never started
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator | Treatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation. |
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| Preventive treatment | Active Comparator | Patients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of start treatment with pancreatic enzymes | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of the nutritional status | Nutritional deficiencies, 1 sample of blood will be drawn (3 times 8ml of blood):
| every three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Bruno, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | South Holland | 3000 WB | Netherlands |
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| Label | URL |
|---|---|
| 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. | View source |
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| Timing of start treatment with pancreatic enzymes | Other | Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms. |
|
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| 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 |