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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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).
Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
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
Time frame: every month during 6 months after inclusion
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)
Time frame: every three months
quality-of-life
SF36 questionnaire
Time frame: 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
Time frame: every month during six months after inclusion
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