Clinical trialPhase 2Terminated
Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma
- Outcome
- Stopped earlySponsorship for trial was halted after company acquisition (Business decision)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 13 April 2018
- Expected end
- 1 October 2019
- Enrollment
- 4 participants
- Sites
- 1
- Primary outcomes
- Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer
- Sponsor
- Other
- Results posted
- 2020-08-03
- Last update
- 3 August 2020
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer [40 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer [84 days after surgery].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count [52 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer [52 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer [52 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer [52 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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 [52 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer [84 days after surgery].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer [52 weeks].