Clincosm LogoSign in Get a demo

EPC: Pancreatic Enzyme Suppletion in Pancreatic Cancer

Sponsor
Foundation for Liver Research (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01401387
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
19
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Timing of start treatment with pancreatic enzymes
  • Other: Timing of start treatment with pancreatic enzymes
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy
Study Start Date :
Oct 1, 2011
Anticipated Primary Completion Date :
May 1, 2013
Anticipated Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard treatment

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
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).
Other Names:
  • Panzytrat 'HL'

    		•
    Active Comparator: Preventive treatment

    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
    Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.
    Other Names:
  • Panzytrat 'HL'

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss. [every month during 6 months after inclusion]

      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

    Secondary Outcome Measures

    1. improvement of the nutritional status [every three months]

      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)

    2. quality-of-life [on a monthly base during 6 months after inclusion]

      SF36 questionnaire

    3. improvement of the nutritional status [every month during six months after inclusion]

      A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erasmus Medical Center Rotterdam Zuid-Holland Netherlands 3000 WB

    Sponsors and Collaborators

    • Foundation for Liver Research

    Investigators

    • Principal Investigator: Marco Bruno, MD, PhD, Erasmus Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Foundation for Liver Research
    ClinicalTrials.gov Identifier:
    NCT01401387
    Other Study ID Numbers:
    • EPC 11-01
    • 2011-003373-28
    First Posted:
    Jul 25, 2011
    Last Update Posted:
    Feb 22, 2013
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Pancreatin
    Pancrelipase

    Study Results

    No Results Posted as of Feb 22, 2013