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2011-10
2014-12
2014-12
67
NCT01587534
National Cancer Center, Korea
National Cancer Center, Korea
INTERVENTIONAL
Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-04-25 | N/A | 2015-04-13 |
2012-04-26 | N/A | 2015-04-15 |
2012-04-30 | N/A | 2015-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: pancreatic enzyme replacement therapy The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day. | DRUG: Norzyme
|
| NO_INTERVENTION: Placebo The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| the change in body weight at eight weeks after the randomisation | the percentage change in body weight at eight weeks after the randomisation | at baseline and 4, 8 week, 24 week |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Frequency and intensity of abdominal pain daily | at baseline and 4, 8 week, 24 week | |
| Frequency of bowel movements per day | at baseline and 4, 8 week, 24 week |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
