Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587534
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea

Tracking Information
First Submitted Date  ICMJE April 25, 2012
First Posted Date  ICMJE April 30, 2012
Last Update Posted Date April 15, 2015
Study Start Date  ICMJE October 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
the change in body weight at eight weeks after the randomisation [ Time Frame: at baseline and 4, 8 week, 24 week ]
the percentage change in body weight at eight weeks after the randomisation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01587534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
  • Frequency and intensity of abdominal pain daily [ Time Frame: at baseline and 4, 8 week, 24 week ]
  • Frequency of bowel movements per day [ Time Frame: at baseline and 4, 8 week, 24 week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)
Official Title  ICMJE Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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.
Other Name: placebo
Study Arms  ICMJE
  • 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.
Publications * Woo SM, Joo J, Kim SY, Park SJ, Han SS, Kim TH, Koh YH, Chung SH, Kim YH, Moon H, Hong EK, Lee WJ. Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial. Pancreatology. 2016 Nov - Dec;16(6):1099-1105. doi: 10.1016/j.pan.2016.09.001. Epub 2016 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2015)
67
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2012)
68
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01587534
Other Study ID Numbers  ICMJE NCCCTS-11-570
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Myung Woo, National Cancer Center, Korea
Study Sponsor  ICMJE National Cancer Center, Korea
Collaborators  ICMJE Pharmbio Korea Co., Ltd.
Investigators  ICMJE
Principal Investigator: Sangmyung Woo, M.D National Cancer Center
PRS Account National Cancer Center, Korea
Verification Date April 2015

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