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

Neuroendocrine Tumor Clinical Trial

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

Status Terminated

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. ;

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumor
• Neuroendocrine Tumors
• Serotonin Syndrome
• Syndrome

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