A Study of Pancrelipase Enzyme Replacement Therapy in People with Advanced Pancreatic Cancer

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Full Title

A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Purpose

People with pancreatic cancer often develop a condition called exocrine pancreatic insufficiency (EPI). With EPI, the pancreas does not make enough of the enzymes that the body needs to break down and absorb nutrients. People with EPI can have various health problems, including weight loss, nausea, indigestion, frequent oily/greasy bowel movements, and malnutrition. This can lead to a decrease in patients’ quality of life.

In this study, researchers are evaluating the use of an enzyme replacement therapy called pancrelipase in people with metastatic pancreatic cancer to see if it helps them gain weight and improves their quality of life. Pancrelipase contains a mixture of digestive enzymes that help the body break down and digest nutrients in food. It is a capsule that is taken orally (by mouth). Participants in this study will be randomly assigned to receive one of two different doses of pancrelipase.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have metastatic pancreatic cancer.
  • No pancreatic enzyme replacement therapy may have been given within two weeks of receiving pancrelipase.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact the office of Dr. Eileen M. O’Reilly at 646-888-4182.

Protocol

21-419

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05642962