Title
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Phase
N/ALead Sponsor
Vanderbilt UniversityStudy Type
InterventionalStatus
TerminatedIndication/Condition
Neuroendocrine Tumor Carcinoid SyndromeIntervention/Treatment
Enterade® ...Study Participants
11This 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.
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.
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
Ancillary studies
Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
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.
