Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

Brief summary public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary [8 weeks]. Count Of Participants, Participants. Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 29.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Weight From Baseline Through the End-of-study Visit [6 months]. Mean, lbs (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=29): -2.1931 (6.163831).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Calories Consumed From Baseline Through the End-of-study Visit [6 months]. Mean, calories (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=27): -169.2075 (969.6394).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Stool Frequency From Baseline Through Cycle 3 Day 1 [8 weeks]. Mean, bowel movements/day (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=27): -0.96296 (2.457038).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Stool Consistency From Baseline Through Cycle 3 Day 1 [8 weeks]. Mean, units on Bristol Stool Form Scale (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=27): -0.407407 (1.906654).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin A [6 months]. Mean, mcg/dL (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): -0.5 (14.70231).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin D [6 months]. Mean, ng/mL (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=21): -5.37619 (12.44841).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin E [6 months]. Mean, mg/L (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=20): 0.495 (3.988863).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K [6 months]. Mean, pg/mL (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=17): -27.47059 (676.6716).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K PT [6 months]. Mean, pg/mL (Standard Deviation). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=21): -0.2190476 (2.82889).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Daily Activity (Steps Taken) From Baseline [6 months]. Mean, steps/day (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): -0.3 (3.8).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Daily Activity (Stairs Climbed) From Baseline [6 months]. Mean, stair steps/day (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 1332.6 (539.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Sleep Disturbance From Baseline [6 months]. Mean, hours/night (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 0.5 (0.83).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Duration of Sleep Disturbances From Baseline [6 months]. Mean, % of nighttime sleep (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 4.43 (1.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Average Heart Rate From Baseline [6 months]. Mean, beats per minute (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 0.8 (2.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Peak Heart Rate From Baseline [6 months]. Mean, BPM (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 9.6 (5.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change in Daily Active Minutes From Baseline [6 months]. Mean, minutes/day (Standard Error). Standard of Care Treatment With Pancreaze (Pancrelipase) (n=30): 3.0 (6.7).