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Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Normal Pancreatic Exocrine Function

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Trial Information

Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss.

Outcome Description:

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

Outcome Time Frame:

every month during 6 months after inclusion

Safety Issue:

No

Principal Investigator

Marco Bruno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasmus Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

EPC 11-01

NCT ID:

NCT01401387

Start Date:

October 2011

Completion Date:

May 2013

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Normal Pancreatic Exocrine Function
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Exocrine Pancreatic Insufficiency
  • Pancreatic Neoplasms

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