Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)
|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|
- 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
- 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 ]
|Study Start Date:||October 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: pancreatic enzyme replacement therapy
The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
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
No Intervention: Placebo
The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587534
|Korea, Republic of|
|NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong‐gu,|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||Sangmyung Woo, M.D||National Cancer Center|