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Brief Title: Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
Official Title: Prospective, Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
Study ID: NCT05078775
Brief Summary: This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with locally advanced and unresectable or metastatic pancreatic adenocarcinoma. Subjects who are eligible to receive two FDA approved first line drug therapies, gemcitabine and nab-paclitaxel (gem+nabP), routinely prescribed in combination for pancreatic cancer may be included in this study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
Oncology Physicians Network, Glendale, California, United States
Cedars-Sinai, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Louisiana State University Health Sciences Center, Shreveport, Louisiana, United States
Atlantic Health, Morristown, New Jersey, United States
xCures - Virtual Site, Raleigh, North Carolina, United States
Sarah Cannon, Nashville, Tennessee, United States
Baptist Hospitals of Southeast Texas, Beaumont, Texas, United States
Baylor Scott & White Health, Temple, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Andrew Hendifar, MD
Affiliation: Cedars-Sinai
Role: PRINCIPAL_INVESTIGATOR