This research study is evaluating a study drug to treat pancreatic exocrine insufficiency (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is recovering from surgery and receiving adjuvant treatment. The study drug involved in this study is: -Zenpep
The FDA (the U.S. Food and Drug Administration) has approved Zenpep as a treatment option for PEI. Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer. In this research study, the investigators are studying whether Zenpep will improve the ability of patients to complete adjuvant treatment for their pancreatic cancer after surgery to remove their tumor. The investigators are also studying if Zenpep will have an effect on nutrition status and quality of life for pancreatic cancer patients after they have had surgery to remove their tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer
Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment
Time frame: 40 weeks
Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer
Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84
Time frame: 84 days after surgery
Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count
Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen
Time frame: 52 weeks
Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer
Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen
Time frame: 52 weeks
Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer
Quantify serum albumin (g/dl ) to correlate pancreatic enzyme replacement therapy with nutrition status before and after surgery and adjuvant therapy for early stage pancreatic cancer
Time frame: 52 weeks
Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer
Measure body weight (in kg) at regular intervals throughout study participation to investigate whether pancreatic enzyme replacement therapy improves nutrition status during surgery and adjuvant treatment for early stage pancreatic cancer
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Time frame: 52 weeks
Evaluate Quality of Life Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer Using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Questionnaire
Subjects to complete EQ-5D-5L at regular intervals throughout study participation. The scale consists of 5 questions, one each to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has answers ranging from No Problems (level 1) to Extreme Problems (level 5). Subjects also to rate their overall health on a given day using the EuroQoL Visual Analog Scale (EQ-VAS) as a part of the EQ-5D-5L, which consists of marking on a visual scale from 0-100 (with 100 being best imaginable health and 0 being worst health imaginable).
Time frame: 52 weeks
Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer
Incidence and severity of postoperative complications graded by Clavien-Dindo classification
Time frame: 84 days after surgery
Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer
Standard grip strength dynamometer measurements at regular intervals throughout the study
Time frame: 52 weeks