Adenocarcinoma of the Pancreas, Normal Pancreatic Exocrine Function
Conditions
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.
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.
Interventions
OTHERTiming 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).
Sponsors
Foundation for Liver Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss. | 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
| Measure | Time frame | Description |
|---|---|---|
| improvement of the nutritional status | 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) |
| quality-of-life | on a monthly base during 6 months after inclusion | SF36 questionnaire |
Countries
Netherlands
Outcome results
None listed