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

NCT ID: NCT04073017

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2021-05-18

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.

Conditions

Neuroendocrine Tumor; Carcinoid Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Enterade

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

Group Type: EXPERIMENTAL

Enterade®

Intervention Type: DIETARY_SUPPLEMENT

Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks

Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

Intervention Type: OTHER

Ancillary studies

Experimental

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

Group Type: EXPERIMENTAL

Enterade®

Intervention Type: DIETARY_SUPPLEMENT

Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks

Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

Intervention Type: OTHER

Ancillary studies

Interventions

Enterade®

Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

FACIT-D

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Entrinsic Bioscience Inc.

INDUSTRY

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Satya Das

Sponsor Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Satya Das, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VICC GI 1943

Identifier Type: -

Identifier Source: org_study_id