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Pancreaze for Pancreatic Cancer (PANCAX-3 Trial)
PANCAX-3 Trial Summary
This trial will study the effects of an advanced formulation of Pancreaze on weight, function, and quality of life in patients with pancreatic cancer.
PANCAX-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPANCAX-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 36 Patients • NCT03924947PANCAX-3 Trial Design
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Who is running the clinical trial?
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- I have lost at least 5% of my weight in the last 6 months due to a chronic illness.I cannot swallow whole capsules.My organ and bone marrow functions are normal.I have been diagnosed with a condition where my pancreas does not produce enough enzymes.My pancreatic cancer is advanced and I am referred to SOCCI-CSMC.My kidney function, measured by creatinine or its clearance, is within the required range.I am able to understand and give consent for my treatment.I agree to use effective birth control or abstain from sex during and for 30 days after the study.I am 18 years old or older.I have a chronic illness that affects how my body absorbs nutrients.I have more than one type of cancer.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am not pregnant or breastfeeding.I am currently taking supplements that contain lipase, protease, and amylase.I am fully active or able to carry out light work.I have a history of fibrosing colonopathy and have been taking high doses of lipase.You are allergic to any of the ingredients in pancreatic enzyme supplements.
- Group 1: Standard of care treatment with Pancreaze (pancrelipase)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the ceiling of participants in this clinical trial?
"Affirmative. According to the information located on clinicaltrials.gov, this medical research is actively seeking volunteers for participation. Initially posted in December of 2020 and recently updated in July 2022, the study needs 30 patients from a single site."
Has Pancrelipase been given the green light by the FDA?
"Our company's analysis rates the safety of Pancrelipase as a 2, due to Phase 2 trial data that provides evidence supporting its security but lacks proof of effectiveness."
Is this clinical trial pioneering a new approach to treatment?
"First investigated in 2011, Pancrelipase has been granted it N/A drug approval and is presently the focus of 7 active clinical trials spanning 10 countries and 38 cities. This initial research was sponsored by Boehringer Ingelheim and involved 60 participants."
In what situation is Pancrelipase typically prescribed?
"Pancrelipase is a recommended treatment for diarrheal symptoms, impaired fat digestion, and post-surgical gastric resection."
Are there any additional investigations involving Pancrelipase?
"Currently, there are seven active studies related to Pancrelipase. Two of these investigations have reached Phase 3 and the majority of them originate from Kansas City, Missouri with a total of fifty two trial sites across the country."
Has recruitment for this study already begun?
"According to clinicaltrials.gov, this medical trial is actively recruiting with its initial posting on December 17th 2020 and most recent update occurring July 15th 2022."
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