Lexington, Kentucky 40536


Purpose:

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®.


Study summary:

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.


Criteria:

Inclusion Criteria: - Cohort 1: Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), AND an elevated serum serotonin or plasma serotonin above the upper limit of normal per reference lab. - Cohort 2: Participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), but are below the cut-point for serotonin elevation. - Age equal to or greater than 18 years old. - ECOG performance status ≤2 (Karnofsky ≥60%) - Ability to tolerate thin liquids by mouth at the time of enrollment. - Ability to understand and the willingness to sign a written informed consent document. - Subject who are willing to take enterade® as instructed will be eligible. Exclusion Criteria: - Known allergy to Stevia. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection. - Participants with active clostridium difficile infection will be ineligible for this study. - Participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or Celiac disease. - Participants with psychiatric illness/social situations that would limit compliance with study requirements. - Patients who have had enterade® within the past 12 months.


NCT ID:

NCT03722511


Primary Contact:

Principal Investigator
Lowell Anthony
Lucille P. Markey Cancer Center at University of Kentucky

Cynthia Leedham, PhD
Phone: 859-257-4470
Email: cleed2@email.uky.edu


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40536
United States

Cynthia Leedham, PhD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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