Pancreatic Enzyme Suppletion in Pancreatic Cancer

NCT01401387 | Withdrawn Phase 4

• 2 other identifiers: EPC 11-012011-003373-28
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Pancreas; Normal Pancreatic Exocrine Function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• improvement of the nutritional status

  every three months

• quality-of-life

  on a monthly base during 6 months after inclusion

• improvement of the nutritional status

  every month during six months after inclusion

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

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

Other: Timing of start treatment with pancreatic enzymes

Preventive treatment

ACTIVE COMPARATOR

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

Other: Timing of start treatment with pancreatic enzymes

Interventions

Timing of start treatment with pancreatic enzymes OTHER

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).

Also known as: Panzytrat 'HL'

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
• \< 18 years.

Sponsors & Collaborators

• Foundation for Liver Research: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3000 WB, Netherlands

Location

Related 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.

Study Officials

• Marco Bruno, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

NL (1)