Pancreatic Enzyme Suppletion in Pancreatic Cancer

Adenocarcinoma of the Pancreas Clinical Trial

— EPC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01401387
• Other study ID #: EPC 11-01
• Secondary ID: 2011-003373-28
• Status: Withdrawn
• Phase: Phase 4
• First received: July 21, 2011
• Last updated: February 21, 2013
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2013
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Timing 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).
• Timing of start treatment with pancreatic enzymes
Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	every three months	No
Secondary	quality-of-life	SF36 questionnaire	on a monthly base during 6 months after inclusion	No
Secondary	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	No

External Links

•   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.