NCT04073017

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumor
• Carcinoid Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Enterade®	Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
OTHER	Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)	Ancillary studies

Timeline

• Start date: 2019-11-04
• Primary completion: 2021-05-18
• Completion: 2021-05-18
• First posted: 2019-08-28
• Last updated: 2021-05-21

Locations

1 site across 1 country: United States