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

Primary Purpose

Neuroendocrine Tumors, Carcinoid Tumor of GI System, Diarrhea

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Amino Acid Based Medical Food/Drink

About this trial

This is an interventional supportive care trial for Neuroendocrine Tumors focused on measuring Enterade, Medical Food/Drink

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Kentucky Markey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

NET with carcinoid syndrome

NET w/o cardinoid syndrome

Arm Description

Participants with NET and carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.

Participants with NET w/o carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.

Outcomes

Primary Outcome Measures

Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample.

ELISA assays will be used to assess pro-inflammatory cytokines IL-1β, IL-6 and TNFα and serum endotoxin from blood samples collected.

Secondary Outcome Measures

Evaluation of increased bacterial translocation and systemic inflammation.

Gut inflammation will be assessed through the analysis of fecal lactoferrin using stool specimens.

Full Information

NCT ID

NCT03722511

First Posted

October 25, 2018

Last Updated

November 2, 2022

Sponsor

Lowell Anthony, MD

Collaborators

Entrinsic Bioscience Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03722511

Brief Title

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

Official Title

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).

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

December 6, 2018 (Actual)

Primary Completion Date

May 18, 2021 (Actual)

Study Completion Date

May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lowell Anthony, MD

Collaborators

Entrinsic Bioscience Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Enterade, Medical Food/Drink

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NET with carcinoid syndrome

Arm Type

Active Comparator

Arm Description

Participants with NET and carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.

Arm Title

NET w/o cardinoid syndrome

Arm Type

Active Comparator

Arm Description

Participants with NET w/o carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

Amino Acid Based Medical Food/Drink

Other Intervention Name(s)

Enterade®

Intervention Description

Study Compound Enterade® is a medical food drink/beverage composed of a proprietary blend of electrolytes and amino acids.

Primary Outcome Measure Information:

Title

Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample.

Description

ELISA assays will be used to assess pro-inflammatory cytokines IL-1β, IL-6 and TNFα and serum endotoxin from blood samples collected.

Time Frame

56 days

Secondary Outcome Measure Information:

Title

Evaluation of increased bacterial translocation and systemic inflammation.

Description

Gut inflammation will be assessed through the analysis of fecal lactoferrin using stool specimens.

Time Frame

56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lowell Anthony

Organizational Affiliation

Lucille P. Markey Cancer Center at University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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