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

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

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.

Study Overview

• Status: Terminated
• Conditions: Neuroendocrine Tumor; Carcinoid Syndrome
• Intervention / Treatment: Dietary supplement: Enterade®; Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enterade; Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.	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; Other Names: FACIT-D
Experimental: Experimental; Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.	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; Other Names: FACIT-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bowel movement frequency	Changes in number of average daily bowel movements from baseline	At 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0	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.	At 8 weeks
Tolerability of enterade®: number of enterade® drinks consumed	Measured by the total number of enterade® drinks consumed	At 8 weeks
Incidents adverse events	NCI CTCAE version 5.0	At 8 weeks
Change in serum electrolytes (Sodium)	The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)	At 8 weeks
Change in serum electrolytes (Potassium)	The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)	At 8 weeks
Change in serum electrolytes (Chloride)	The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)	At 8 weeks
Change in serum electrolytes (Magnesium)	The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )	At 8 weeks
Change in serum electrolytes (Phosphorous)	The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )	At 8 weeks
Differences in intravenous fluid requirements	Measured by the number of incidence requiring intravenous fluid before and after taking enterade®	At 8 weeks
Differences in use of standard-of-care anti-diarrhea medications	Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade®	At 8 weeks
Differences in bloating	Measured by reported incidence of bloating before and after taking enterade®	At 8 weeks
Differences in flatulence	Measured by reported incidence of flatulence before and after taking enterade®	At 8 weeks
Changes in weight	Measured by fluctuation in weight before and after taking enterade®	At 8 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: Entrinsic Bioscience Inc.
• Investigators: Principal Investigator: Satya Das, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Disease; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Syndrome; Neuroendocrine Tumors; Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome
• Other Study ID Numbers: VICC GI 1943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No