NCT03722511

Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

A Phase 2 Study Evaluating a Proprietary Amino Acid Based Medical Food (Enterade®) in Patients With Quality of Life Limiting Diarrhea Due to Carcinoid Syndrome and Other Neuroendocrine Tumors (NET).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Lowell Anthony, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control. Secondary Objectives: * To assess subject reported health-related quality of life in subjects before and after compound administration. * To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day. * To evaluate changes in serum electrolytes before and after administration of Eenterade®. * To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period. * To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period. * To compare subjective feeling of bloating and flatulence before and after administration of Enterade®. * To evaluate changes in patient weight before and after administration of Enterade®.

Detailed description

This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency. * This is a non-randomized, supportive-care study. * Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics. * During the screening visit, immediately after signing informed consent, the participant will be given both flavors of enterade® (original vanilla and refreshing orange) to test tolerability and taste. * Eligible subjects will be given a stool diary and will be asked to document daily stool output (frequency and consistency of stool), use of anti-diarrheal medication and gastrointestinal discomforts (bloating, cramping). * All lab and screening tests should be completed within 2 weeks prior to registration/initiation of study. * The study is broken into 3 distinct segments and will apply to all enrolled participants: Baseline observation (Weeks 1-4), Enterade® administration period (4 weeks), Post-Enterade® Period (4 weeks). * After relapse of diarrhea is documented or the 4 weeks of post-Enterade® observation are completed (whatever happens first), participants will be given the option to restart Enterade® for 1 additional month.

Conditions

• Neuroendocrine Tumors
• Carcinoid Tumor of GI System
• Diarrhea
• Carcinoid Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Amino Acid Based Medical Food/Drink	Study Compound Enterade® is a medical food drink/beverage composed of a proprietary blend of electrolytes and amino acids.

Timeline

• Start date: 2018-12-06
• Primary completion: 2021-05-18
• Completion: 2021-05-18
• First posted: 2018-10-29
• Last updated: 2022-11-03

Locations

1 site across 1 country: United States