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

Stopped early · Not applicable

Conditions studied: Neuroendocrine Tumor, Carcinoid Syndrome

In brief

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.

Key facts

Study ID

NCT04073017

Run by

Vanderbilt-Ingram Cancer Center

People needed

11

Starts

2019-11-04

Expected to finish

2021-05-18

Last updated by the study team

2021-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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