Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
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About
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.
Full 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.
Enrollment
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
11 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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