Spots Global Cancer Trial Database for Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

Official Title: Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

Study ID: NCT04073017

Conditions

Neuroendocrine Tumor

Carcinoid Syndrome

Interventions

Enterade®

Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

Study Description

Brief 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.

Detailed 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.