Back to resultsEnterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Primary Purpose
Neuroendocrine Tumor, Carcinoid Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enterade®
Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Sponsored by
About this trial
This is an interventional supportive care trial for Neuroendocrine Tumor
Eligibility Criteria
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.
Sites / Locations
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Enterade
Experimental
Arm Description
Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Outcomes
Primary Outcome Measures
Change in bowel movement frequency
Changes in number of average daily bowel movements from baseline
Secondary Outcome Measures
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.
Tolerability of enterade®: number of enterade® drinks consumed
Measured by the total number of enterade® drinks consumed
Incidents adverse events
NCI CTCAE version 5.0
Change in serum electrolytes (Sodium)
The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)
Change in serum electrolytes (Potassium)
The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)
Change in serum electrolytes (Chloride)
The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)
Change in serum electrolytes (Magnesium)
The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )
Change in serum electrolytes (Phosphorous)
The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )
Differences in intravenous fluid requirements
Measured by the number of incidence requiring intravenous fluid before and after taking enterade®
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®
Differences in bloating
Measured by reported incidence of bloating before and after taking enterade®
Differences in flatulence
Measured by reported incidence of flatulence before and after taking enterade®
Changes in weight
Measured by fluctuation in weight before and after taking enterade®
Full Information
NCT ID
NCT04073017
First Posted
August 26, 2019
Last Updated
May 18, 2021
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
Entrinsic Bioscience Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04073017
Brief Title
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Official Title
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
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
Entrinsic Bioscience Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor, Carcinoid Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enterade
Arm Type
Experimental
Arm Description
Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Enterade®
Intervention Description
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
Intervention Type
Other
Intervention Name(s)
Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Other Intervention Name(s)
FACIT-D
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in bowel movement frequency
Description
Changes in number of average daily bowel movements from baseline
Time Frame
At 8 weeks
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0
Description
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.
Time Frame
At 8 weeks
Title
Tolerability of enterade®: number of enterade® drinks consumed
Description
Measured by the total number of enterade® drinks consumed
Time Frame
At 8 weeks
Title
Incidents adverse events
Description
NCI CTCAE version 5.0
Time Frame
At 8 weeks
Title
Change in serum electrolytes (Sodium)
Description
The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)
Time Frame
At 8 weeks
Title
Change in serum electrolytes (Potassium)
Description
The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)
Time Frame
At 8 weeks
Title
Change in serum electrolytes (Chloride)
Description
The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)
Time Frame
At 8 weeks
Title
Change in serum electrolytes (Magnesium)
Description
The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )
Time Frame
At 8 weeks
Title
Change in serum electrolytes (Phosphorous)
Description
The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )
Time Frame
At 8 weeks
Title
Differences in intravenous fluid requirements
Description
Measured by the number of incidence requiring intravenous fluid before and after taking enterade®
Time Frame
At 8 weeks
Title
Differences in use of standard-of-care anti-diarrhea medications
Description
Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade®
Time Frame
At 8 weeks
Title
Differences in bloating
Description
Measured by reported incidence of bloating before and after taking enterade®
Time Frame
At 8 weeks
Title
Differences in flatulence
Description
Measured by reported incidence of flatulence before and after taking enterade®
Time Frame
At 8 weeks
Title
Changes in weight
Description
Measured by fluctuation in weight before and after taking enterade®
Time Frame
At 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satya Das, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
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