Enzyme therapy aims to fight wasting in pancreatic cancer patients
NCT ID NCT04098237
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a high-dose pancreatic enzyme replacement (Pancreaze) to standard care can help patients with advanced pancreatic cancer who have weight loss and trouble digesting food. About 36 adults will take the enzymes with meals and snacks for 8 weeks. The goal is to see if patients can stick with the therapy and if it helps stabilize weight, improve nutrition, and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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36 people
The number who actually took part.
- Started
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Dec 2020
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Borderline resectable, locally advanced, and advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC (Samuel Oschin Cancer Center - Cedars Sinai Medical Center) 2. Age ≥ 18 years. 3. ECOG performance status 0-1 or Karnofsky PS \>60% 4. Clinical diagnosis of exocrine pancreatic insufficiency 5. Cachexia defined as at least 5% weight loss in the presence of chronic illness, within any 6-month period prior to screening OR as documented by the medical physician based on standard diagnosis of cachexia 6. Life expectancy of greater than 3 months, in the opinion of the investigator. 7. Patients must have normal organ and marrow function as defined below: * Absolute Neutrophil Count (ANC) ≥ 500/mcL * Platelets ≥ 50,000/mcL * Total bilirubin ≤ 5X upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤ 5 X ULN * Creatinine OR creatinine clearance ≤ 3 times the upper limit of normal OR ≥ 30 mL/min/1.73 m² for patients with creatinine levels above normal. * Note: Patients with biliary stents are eligible provided that all other inclusion criteria are met. 8. Woman of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of signing the informed consent form, for the duration of study participation, and for at least 30 days after discontinuing from study treatment. 9. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 2. Women who are pregnant or are breastfeeding 3. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent 4. Unable to swallow intact capsules 5. Fibrosing colonopathy: Patients with history of fibrosing colonopathy have been reported to experience advancement to colonic strictures with doses of lipase\>6000 units/kg/meal over prolonged periods of time. 6. History of chronic illness associated with malabsorption or nutrient deficiency including but not limited to chronic pancreatitis, cystic fibrosis, celiac disease, Crohn's disease, pernicious anemia and/or prior intestinal resection. 7. Coexistent other primary malignancy 8. Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study 9. Active drug abuse or intoxication with any substance including alcohol (blood alcohol content \>0.08%, legal driving limit) 10. Known allergy to any of the active ingredients in pancreatic enzyme supplementation 11. Concurrent use of pancreatic enzyme supplementation or over the counter supplements which contain lipase, protease, and amylase as active ingredients
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Other studies related to the condition(s) this trial covers.
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