Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
the change in body weight at eight weeks after the randomisation
Outcome Description:
the percentage change in body weight at eight weeks after the randomisation
Outcome Time Frame:
at baseline and 4, 8 week, 24 week
Safety Issue:
No
Authority:
Korea: Institutional Review Board
Study ID:
NCCCTS-11-570
NCT ID:
NCT01587534
Start Date:
October 2011
Completion Date:
December 2014
Related Keywords:
- Pancreatic Cancer
- Unresectable Pancreatic cancer
- Pancreatic Neoplasms
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