Trial Outcomes & Findings for Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma (NCT NCT03469258)
NCT ID: NCT03469258
Last Updated: 2020-08-03
Results Overview
Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment
TERMINATED
PHASE2
4 participants
40 weeks
2020-08-03
Participant Flow
Participant milestones
| Measure |
Zenpep
* 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
Pancrelipase: 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.
|
|---|---|
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Overall Study
STARTED
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4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Zenpep
* 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
Pancrelipase: 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.
|
|---|---|
|
Overall Study
Upon surgery, did not meet criteria
|
4
|
Baseline Characteristics
Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 40 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 84 days after surgeryPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 84 days after surgeryPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
Incidence and severity of postoperative complications graded by Clavien-Dindo classification
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.
Standard grip strength dynamometer measurements at regular intervals throughout the study
Outcome measures
Outcome data not reported
Adverse Events
Zenpep
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
A. James Moser, MD
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place