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2020-12-17
2024-01-12
2027-01
36
NCT04098237
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
INTERVENTIONAL
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 40 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-09-19 | 2024-12-11 | 2025-05-21 |
2019-09-20 | 2025-02-18 | 2025-05-31 |
2019-09-23 | 2025-03-07 | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Standard of care treatment with Pancreaze (pancrelipase) Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks | DRUG: Pancrelipase
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary | Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary. | 8 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Mean Change in Weight From Baseline Through the End-of-study Visit | 6 months | |
| Mean Change in Calories Consumed From Baseline Through the End-of-study Visit | As measured by Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. The ASA24 is a system to collect 24-hour food recalls and provide complete nutrient analysis of the foods and beverages consumed during the collection timeframe. The tool is used in this study to measure total calories consumed. | 6 months |
| Mean Change in Stool Frequency From Baseline Through Cycle 3 Day 1 | As measured by patient reported number of bowel movements in the past 24 hours. In this study, higher numbers represent more severe symptoms; a reduction in number of bowel movements in the past 24 hours represents improvement in symptoms. | 8 weeks |
| Mean Change in Stool Consistency From Baseline Through Cycle 3 Day 1 | As measured by patient reported stool consistency using the Bristol Stool Chart.The Bristol Stool Chart is a diagnostic scale to classify stool into 7 different groups, ranging from Type 1-7 (indicating solid to liquid consistency or time spent longest in the bowel to least time in the bowel). A normal stool should be either Type 3 or Type 4 (middle of the scale). Worsening of stool consistency is denoted by classifications located closer to the extreme ends of the scale (Type 1 or Type 7). | 8 weeks |
| Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin A | 6 months | |
| Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin D | 6 months | |
| Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin E | 6 months | |
| Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K | 6 months | |
| Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K PT | 6 months | |
| Change in Microbiome From Baseline | Microbiome analysis of stool samples | 8 weeks |
| Mean Change in Daily Activity (Steps Taken) From Baseline | As measured by continuous daily wearable activity monitor | 6 months |
| Mean Change in Daily Activity (Stairs Climbed) From Baseline | As measured by continuous daily wearable activity monitor | 6 months |
| Mean Change in Sleep Disturbance From Baseline | As measured by continuous daily wearable activity monitor | 6 months |
| Mean Change in Duration of Sleep Disturbances From Baseline | As measured by continuous daily wearable activity monitor. An absolute change in the percentage of time during nighttime sleep in which participants experienced sleep disturbance is being reported.An absolute change in percent is understood to be calculated as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline). | 6 months |
| Mean Change in Average Heart Rate From Baseline | As measured by continuous daily wearable activity monitor | 6 months |
| Mean Change in Peak Heart Rate From Baseline | As measured by continuous daily wearable activity monitor | 6 months |
| Mean Change in Daily Active Minutes From Baseline | As measured by continuous daily wearable activity monitor | 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
