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

Neuroendocrine Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04073017
• Other study ID #: VICC GI 1943
• Status: Terminated
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: May 18, 2021

Study information

• Verified date: May 2021
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumor
• Neuroendocrine Tumors
• Serotonin Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	Entrinsic Bioscience Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bowel movement frequency	Changes in number of average daily bowel movements from baseline	At 8 weeks
Secondary	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
Secondary	Tolerability of enterade®: number of enterade® drinks consumed	Measured by the total number of enterade® drinks consumed	At 8 weeks
Secondary	Incidents adverse events	NCI CTCAE version 5.0	At 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Differences in intravenous fluid requirements	Measured by the number of incidence requiring intravenous fluid before and after taking enterade®	At 8 weeks
Secondary	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
Secondary	Differences in bloating	Measured by reported incidence of bloating before and after taking enterade®	At 8 weeks
Secondary	Differences in flatulence	Measured by reported incidence of flatulence before and after taking enterade®	At 8 weeks
Secondary	Changes in weight	Measured by fluctuation in weight before and after taking enterade®	At 8 weeks