Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Pancrelipase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Variants or mixed histology will be included if the predominant histology is adenocarcinoma. Participants must have potentially resectable pancreatic cancer defined as: (1) no detectable metastases (2) signed consent for attempted resection of pancreatic cancer per treating surgeon. ECOG performance status ≤2. Age >18 years. Participants <18 years old are excluded from this study because subsequent adjuvant therapy is based on therapy guidelines in the adult population. Willingness to consider adjuvant therapy following surgical resection of disease, signed in the consent form attestation. Ability to understand and willingness to provide written informed consent. Pre-operative laboratory values adequate to undergo resection of pancreatic cancer, as defined below: Hemoglobin > 7.0 g/dL; Platelets ≥ 40,000/mL; Creatinine < 2.5 mg/dL or; Creatinine clearance ≥ 20 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. Exclusion Criteria: Pancreatic resection not performed. Intraoperative findings and unforeseen medical exigent circumstances may preclude pancreatic resection. Such outcomes include undetected metastases or vascular involvement, which preclude resection with intent to cure, as well as perioperative medical events including cardiopulmonary complications. Final pathology other than pancreatic ductal adenocarcinoma or primary component other than adenocarcinoma. Any prior chemotherapy and/or radiation for pancreatic cancer at the time of study enrollment, including neoadjuvant chemotherapy and/or radiation therapy. Second malignancy with active disease. History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to pancrelipase Pregnant women are excluded from this study because subsequent adjuvant therapy needed for the primary endpoint is teratogenic. Pancrelipase is category C. Animal reproduction studies have not been conducted on pancrelipase and minimal data is available. Participants unable to self-administer pancrelipase. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Participants who are receiving any other investigational agents. Participant unable to tolerate oral nutrition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zenpep<br>Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously. Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date | Drug: Pancrelipase<br>* 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.<br>* Other names: Zenpep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer | Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84 | 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 | 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 | 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 | 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 | 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). | 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 | 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 | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer