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

NCT04073017 | Terminated DMC

• 1 other identifier: VICC GI 1943
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumor; Carcinoid Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in bowel movement frequency

  Changes in number of average daily bowel movements from baseline

  At 8 weeks

Secondary Outcomes (13)

• Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0

  At 8 weeks

• Tolerability of enterade®: number of enterade® drinks consumed

  At 8 weeks

• Incidents adverse events

  At 8 weeks

• Change in serum electrolytes (Sodium)

  At 8 weeks

• Change in serum electrolytes (Potassium)

  At 8 weeks

Study Arms (2)

Enterade

EXPERIMENTAL

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

Dietary Supplement: Enterade®; Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

Experimental

EXPERIMENTAL

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

Dietary Supplement: Enterade®; Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)

Interventions

Enterade® DIETARY_SUPPLEMENT

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

Enterade; Experimental

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

Ancillary studies

Also known as: FACIT-D

Enterade; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Entrinsic Bioscience Inc.: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Serotonin Syndrome

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Satya Das, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: November 4, 2019
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)