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Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
November 4, 2019
Primary Completion Date
May 18, 2021
Completion Date
May 18, 2021
Last Updated
May 21, 2021
11
ACTUAL participants
Enterade®
DIETARY_SUPPLEMENT
Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
OTHER
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT05746208
NCT06228066
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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