Pancreatic Enzyme Suppletion in Pancreatic Cancer (EPC)

Foundation for Liver Research

Status and phase: Withdrawn; Phase 4

Conditions: Normal Pancreatic Exocrine Function; Adenocarcinoma of the Pancreas

Treatments: Other: Timing of start treatment with pancreatic enzymes

Study type: Interventional

Funder types: Other

Identifiers

NCT01401387

2011-003373-28 (EudraCT Number)

EPC 11-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard treatment

Active Comparator group

Description:

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

Treatment:

Other: Timing of start treatment with pancreatic enzymes

Other: Timing of start treatment with pancreatic enzymes

Preventive treatment

Active Comparator group

Description:

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

Treatment:

Other: Timing of start treatment with pancreatic enzymes

Other: Timing of start treatment with pancreatic enzymes