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

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ClinicalTrials.gov Identifier: NCT03722511
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
Entrinsic Health Solutions, Inc.
Information provided by (Responsible Party):
Lowell Anthony, MD, University of Kentucky

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®.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Carcinoid Tumor of GI System Diarrhea Carcinoid Syndrome Dietary Supplement: Amino Acid Based Medical Food/Drink Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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).
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2030


Arm Intervention/treatment
Active Comparator: NET with carcinoid syndrome
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.
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.
Other Name: Enterade®

Active Comparator: NET w/o cardinoid syndrome
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.
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.
Other Name: Enterade®




Primary Outcome Measures :
  1. Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample. [ Time Frame: 56 days ]
    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 :
  1. Evaluation of increased bacterial translocation and systemic inflammation. [ Time Frame: 56 days ]
    Gut inflammation will be assessed through the analysis of fecal lactoferrin using stool specimens.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722511


Contacts
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Contact: Cynthia Leedham, PhD 859-257-4470 cleed2@email.uky.edu

Locations
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United States, Kentucky
University of Kentucky Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Cynthia Leedham, PhD         
Principal Investigator: Lowell Anthony, MD         
Sponsors and Collaborators
University of Kentucky
Entrinsic Health Solutions, Inc.
Investigators
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Principal Investigator: Lowell Anthony Lucille P. Markey Cancer Center at University of Kentucky

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Responsible Party: Lowell Anthony, MD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03722511     History of Changes
Other Study ID Numbers: MCC-18-GI-101-EHS
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lowell Anthony, MD, University of Kentucky:
Enterade
Medical Food/Drink

Additional relevant MeSH terms:
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Syndrome
Neoplasms
Diarrhea
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Gastrointestinal Neoplasms
Digestive System Neoplasms
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases