Pancreatic Enzyme Suppletion in Pancreatic Cancer (EPC)

This study has been withdrawn prior to enrollment.
(study never started)
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01401387
First received: July 21, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Adenocarcinoma of the Pancreas
Normal Pancreatic Exocrine Function
Other: Timing of start treatment with pancreatic enzymes
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss. [ Time Frame: every month during 6 months after inclusion ] [ Designated as safety issue: No ]
    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:
  • improvement of the nutritional status [ Time Frame: every three months ] [ Designated as safety issue: No ]

    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)

  • quality-of-life [ Time Frame: on a monthly base during 6 months after inclusion ] [ Designated as safety issue: No ]
    SF36 questionnaire

  • improvement of the nutritional status [ Time Frame: every month during six months after inclusion ] [ Designated as safety issue: No ]
    A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms


Enrollment: 0
Study Start Date: October 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Panzytrat 'HL'

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401387

Locations
Netherlands
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
  More Information

Additional Information:
No publications provided

Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT01401387     History of Changes
Other Study ID Numbers: EPC 11-01, 2011-003373-28
Study First Received: July 21, 2011
Last Updated: February 21, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Adenocarcinoma
Exocrine Pancreatic Insufficiency
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancreatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014