Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs
Study Details
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:
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To assess subject reported health-related quality of life in subjects before and after compound administration.
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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.
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To evaluate changes in serum electrolytes before and after administration of Eenterade®.
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To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period.
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To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period.
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To compare subjective feeling of bloating and flatulence before and after administration of Enterade®.
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To evaluate changes in patient weight before and after administration of Enterade®.
Condition or Disease | Intervention/Treatment | Phase |
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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.
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This is a non-randomized, supportive-care study.
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Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics.
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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.
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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).
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All lab and screening tests should be completed within 2 weeks prior to registration/initiation of study.
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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).
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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 Names:
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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 Names:
|
Outcome Measures
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. [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
- Evaluation of increased bacterial translocation and systemic inflammation. [56 days]
Gut inflammation will be assessed through the analysis of fecal lactoferrin using stool specimens.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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.
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Age equal to or greater than 18 years old.
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ECOG performance status ≤2 (Karnofsky ≥60%)
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Ability to tolerate thin liquids by mouth at the time of enrollment.
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Ability to understand and the willingness to sign a written informed consent document.
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Subject who are willing to take enterade® as instructed will be eligible.
Exclusion Criteria:
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Known allergy to Stevia.
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Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection.
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Participants with active clostridium difficile infection will be ineligible for this study.
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Participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or Celiac disease.
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Participants with psychiatric illness/social situations that would limit compliance with study requirements.
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Patients who have had enterade® within the past 12 months.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Kentucky Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Lowell Anthony, MD
- Entrinsic Bioscience Inc.
Investigators
- Principal Investigator: Lowell Anthony, Lucille P. Markey Cancer Center at University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-18-GI-101-EHS