Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

Overview

This is an open-label phase II basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.

Full Title of Study: “Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 18, 2021

Detailed Description

Primary Objective: – To assess the ability of enterade to reduce bowel movement frequency in NET patients with and without carcinoid syndrome. Secondary Objectives: – To assess subject-reported health-related quality of life measures in subjects before and after compound administration. – To characterize the side effect profile and tolerability of the compound as measured by the number of total 8-oz enterade® bottles consumed throughout the trial. – To evaluate changes in serum electrolytes before and after administration of the compound. – To assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade® period. – To evaluate differences in utilization of standard-of-care anti-diarrheal medications in patients between observation period and enterade® period. – To compare subjective bloating and flatulence in patients before and after administration of the compound. – To evaluate changes in patient weight before and after administration of the compound. Exploratory Objectives: – To assess changes in serum and stool inflammatory markers before and after the study compound. – To evaluate changes in fecal lactoferrin before and after study compound administration.

Interventions

  • Dietary Supplement: Enterade®
    • Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
  • Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Enterade
    • Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
  • Experimental: Experimental
    • Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in bowel movement frequency
    • Time Frame: At 8 weeks
    • Changes in number of average daily bowel movements from baseline

Secondary Measures

  • Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0
    • Time Frame: At 8 weeks
    • The FACIT-D is a questionnaire composed of 5 categories (physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns). Each category has 6-11 questions which are scored on a 0 (not at all) to 4 (very much) scale. Groups of categories are scored differently. For example in the additional concerns, emotional well-being and physical well-being categories, a higher score reflects poorer quality of life. In the family well-being and functional well-being categories, a higher score indicates better outcomes.
  • Tolerability of enterade®: number of enterade® drinks consumed
    • Time Frame: At 8 weeks
    • Measured by the total number of enterade® drinks consumed
  • Incidents adverse events
    • Time Frame: At 8 weeks
    • NCI CTCAE version 5.0
  • Change in serum electrolytes (Sodium)
    • Time Frame: At 8 weeks
    • The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)
  • Change in serum electrolytes (Potassium)
    • Time Frame: At 8 weeks
    • The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)
  • Change in serum electrolytes (Chloride)
    • Time Frame: At 8 weeks
    • The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)
  • Change in serum electrolytes (Magnesium)
    • Time Frame: At 8 weeks
    • The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )
  • Change in serum electrolytes (Phosphorous)
    • Time Frame: At 8 weeks
    • The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )
  • Differences in intravenous fluid requirements
    • Time Frame: At 8 weeks
    • Measured by the number of incidence requiring intravenous fluid before and after taking enterade®
  • Differences in use of standard-of-care anti-diarrhea medications
    • Time Frame: At 8 weeks
    • Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade®
  • Differences in bloating
    • Time Frame: At 8 weeks
    • Measured by reported incidence of bloating before and after taking enterade®
  • Differences in flatulence
    • Time Frame: At 8 weeks
    • Measured by reported incidence of flatulence before and after taking enterade®
  • Changes in weight
    • Time Frame: At 8 weeks
    • Measured by fluctuation in weight before and after taking enterade®

Participating in This Clinical Trial

Inclusion Criteria

Carcinoid syndrome: Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which includes somatostatin analogs and/or Telotristat Ethyl). Additionally, a plasma 5-HIAA, or a urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening. Non-Carcinoid Syndrome: 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), but do not have elevated results for one of the following: plasma 5-HIAA, or 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening

  • 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 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 3 months. – Pregnant or breastfeeding women. The safety of enterade® has not been validated in this patient population.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt-Ingram Cancer Center
  • Collaborator
    • Entrinsic Bioscience Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Satya Das, Sponsor Investigator – Vanderbilt-Ingram Cancer Center
  • Overall Official(s)
    • Satya Das, MD, Principal Investigator, Vanderbilt-Ingram Cancer Center

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