Pancreatic Cancer Clinical Trial
Official title:
Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Verified date | February 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
Status | Terminated |
Enrollment | 16 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients 18-80 years - Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis) - On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study - Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool Exclusion Criteria: - Common bile duct obstruction resulting in obstructive jaundice - Celiac disease - Crohn's disease - Benign pancreatic conditions - Bowel obstruction - Surgically altered bowel anatomy |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Massimo Raimondo, M.D. | Digestive Care, Inc. |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Weight | Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment. | Baseline, 4 weeks, 10 weeks | |
Secondary | Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks | Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life). | Baseline, 4 weeks | |
Secondary | Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks | Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life). | Baseline, 10 weeks | |
Secondary | Change in Body Weight Composition | Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment. | Baseline, 4 weeks, 10 weeks |
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