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
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Norzyme
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 68
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pancreatic enzyme replacement therapy
The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
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.
No Intervention: Placebo
The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances.

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.

  Eligibility

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

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
  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: NCT01587534

Contacts
Contact: Sangmyung . Woo, M.D 82-31-920-1733 wsm@ncc.re.kr

Locations
Korea, Republic of
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong‐gu, Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: SANGMYUNG . WOO, MD    82-31-920-1733    wsm@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Pharmbio Korea Co., Ltd.
  More Information

No publications provided

Responsible Party: Sang Myung Woo, Staff physician, Ceneter for Liver Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01587534     History of Changes
Other Study ID Numbers: NCCCTS-11-570
Study First Received: April 25, 2012
Last Updated: April 26, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Unresectable Pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014