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Clinical Trial Summary

This is an open-label phase II basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.


Clinical Trial Description

Primary Objective: - To assess the ability of enterade to reduce bowel movement frequency in NET patients with and without carcinoid syndrome. Secondary Objectives: - To assess subject-reported health-related quality of life measures in subjects before and after compound administration. - To characterize the side effect profile and tolerability of the compound as measured by the number of total 8-oz enterade® bottles consumed throughout the trial. - To evaluate changes in serum electrolytes before and after administration of the compound. - To assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade® period. - To evaluate differences in utilization of standard-of-care anti-diarrheal medications in patients between observation period and enterade® period. - To compare subjective bloating and flatulence in patients before and after administration of the compound. - To evaluate changes in patient weight before and after administration of the compound. Exploratory Objectives: - To assess changes in serum and stool inflammatory markers before and after the study compound. - To evaluate changes in fecal lactoferrin before and after study compound administration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04073017
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Terminated
Phase N/A
Start date November 4, 2019
Completion date May 18, 2021

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