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Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by National Cancer Center, Korea
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01587534
First received: April 25, 2012
Last updated: April 26, 2012
Last verified: April 2012

April 25, 2012
April 26, 2012
October 2011
December 2014   (final data collection date for primary outcome measure)
the change in body weight at eight weeks after the randomisation [ Time Frame: at baseline and 4, 8 week, 24 week ] [ Designated as safety issue: No ]
the percentage change in body weight at eight weeks after the randomisation
Same as current
Complete list of historical versions of study NCT01587534 on ClinicalTrials.gov Archive Site
  • Frequency and intensity of abdominal pain daily [ Time Frame: at baseline and 4, 8 week, 24 week ] [ Designated as safety issue: No ]
  • Frequency of bowel movements per day [ Time Frame: at baseline and 4, 8 week, 24 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)
Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer

The investigators planned a prospective, randomized, placebo controlled trial to test the hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in combination with dietary counseling.

Pancreatic cancer has the worst overall prognosis with fewer than 3% of affected patients alive five years after the initial diagnosis. It is the fourth leading cause of death from cancer in Korea. 80-90% of patients have locally unresectable or advanced metastatic disease and for these patients only palliative treatment options remain. Symptoms include obstructive jaundice, duodenal obstruction, pain, and weight loss. Palliative treatment is mainly directed against the former three. Interventions to prevent (further) weight loss have as yet received little or no attention, in spite of the frequent occurrence of this symptom. About 90% of patients with pancreatic carcinoma have weight loss at the time of diagnosis. In addition, Weight loss prior to chemotherapy was found to have a prognostic effect on survival in a range of different tumor types.

There is a limited range of studies investigating the incidence of exocrine insufficiency in pancreatic cancer. Studies available indicate a high incidence of exocrine insufficiency in unresectable pancreatic cancer patients and patients before and after pancreatic cancer surgery. The previous reports showed that 68-92% of pancreatic cancer patients were exocrine insufficient. Such high incidences of exocrine insufficiency in pancreatic cancer patients support the use of pancreatic enzyme replacement therapy in this patient group. The guidelines for the management of patients with pancreatic cancer periampullary and ampullary carcinoma published in Gut promote the use of pancreatic enzyme replacement therapy to maintain weight and to increase quality of life in this patient group. However, studies evaluating the efficacy of pancreatic enzyme replacement therapy in pancreatic cancer are lacking to date. There have been no systematic reviews and only one randomized control trial involving a small sample of 21 patients with unresectable cancer of the pancreatic cancer.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pancreatic Cancer
Drug: Norzyme
Patients will be randomized to receive either pancreatic enzyme replacement therapy or placebo. Patients will use two capsules three times daily during main meals and one capsule three times daily during in between snacks. The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
  • Experimental: pancreatic enzyme replacement therapy
    The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
    Intervention: Drug: Norzyme
  • No Intervention: Placebo
    The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • To be eligible for inclusion, each patient must fulfill each of the following criteria:

    1. Subjects with unresectable pancreatic cancer preferably proven by cytology or histology
    2. not eligible for surgery because of poor general condition, local unresectability, or advanced disease with metastases
    3. Age over 18 years old
    4. Performance status (ECOG scale): 0-2
    5. Agree to record daily food intake
    6. Patients should sign a written informed consent before study entry

Exclusion Criteria:

  • Patients will be excluded from the study for any of the following reasons:

    1. History of major gastrointestinal surgery
    2. history of chronic gastrointestinal disease (for example, Crohn's disease)
    3. Diabetes decompensated
    4. Diabetes mellitus with severe gastroparesis
    5. presence of pancreatic pseudocysts impeding gastric or duodenal passage
    6. any use of antacids, mucosal protective agents, H 2 receptor antagonists, or proton pump inhibitors that could not be discontinued
    7. concomitant medication affecting gastroduodenal motility (e.g. metoclopramide and erythromycin), or interfering with bile secretion (e.g. bile acids)
    8. Abusive use of alcohol in the three months preceding the study;
    9. known allergy to pancreatin
    10. Any major surgery within 4 weeks prior to study treatment
    11. Pregnant or lactating woman
    12. Any patients judged by the investigator to be unfit to participate in the study
Both
18 Years and older
No
Contact: Sangmyung . Woo, M.D 82-31-920-1733 wsm@ncc.re.kr
Korea, Republic of
 
NCT01587534
NCCCTS-11-570
No
Sang Myung Woo, National Cancer Center, Korea
National Cancer Center, Korea
Pharmbio Korea Co., Ltd.
Not Provided
National Cancer Center, Korea
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP