Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Enterade |
Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. |
|
|
Experimental Experimental |
Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. |
|
More Details
- Status
- Terminated
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
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.