Carcinoid Syndrome, Neuroendocrine Tumor
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTEnterade®
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
OTHERFunctional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Ancillary studies
Sponsors
Entrinsic Bioscience Inc.
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bowel movement frequency | At 8 weeks | Changes in number of average daily bowel movements from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of enterade®: number of enterade® drinks consumed | At 8 weeks | Measured by the total number of enterade® drinks consumed |
| Incidents adverse events | At 8 weeks | NCI CTCAE version 5.0 |
| Change in serum electrolytes (Sodium) | At 8 weeks | The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L) |
| Change in serum electrolytes (Potassium) | At 8 weeks | The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L) |
| Change in serum electrolytes (Chloride) | At 8 weeks | The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L) |
| Change in serum electrolytes (Magnesium) | At 8 weeks | The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL ) |
| Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0 | At 8 weeks | The FACIT-D is a questionnaire composed of 5 categories (physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns). Each category has 6-11 questions which are scored on a 0 (not at all) to 4 (very much) scale. Groups of categories are scored differently. For example in the additional concerns, emotional well-being and physical well-being categories, a higher score reflects poorer quality of life. In the family well-being and functional well-being categories, a higher score indicates better outcomes. |
| Differences in intravenous fluid requirements | At 8 weeks | Measured by the number of incidence requiring intravenous fluid before and after taking enterade® |
| Differences in use of standard-of-care anti-diarrhea medications | At 8 weeks | Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade® |
| Differences in bloating | At 8 weeks | Measured by reported incidence of bloating before and after taking enterade® |
| Differences in flatulence | At 8 weeks | Measured by reported incidence of flatulence before and after taking enterade® |
| Changes in weight | At 8 weeks | Measured by fluctuation in weight before and after taking enterade® |
| Change in serum electrolytes (Phosphorous) | At 8 weeks | The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL ) |
Countries
United States
Outcome results
None listed