Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
- Conditions
- Neuroendocrine TumorCarcinoid Syndrome
- Interventions
- Dietary Supplement: Enterade®Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
- Registration Number
- NCT04073017
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enterade Enterade® Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. Enterade Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. Experimental Enterade® Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks. Experimental Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0) Non-Carcinoid Syndrome: Participants will drink a bottle of Enterade two time per day for 4 weeks.
- Primary Outcome Measures
Name Time Method Change in bowel movement frequency At 8 weeks Changes in number of average daily bowel movements from baseline
- Secondary Outcome Measures
Name Time Method Tolerability of enterade®: number of enterade® drinks consumed At 8 weeks Measured by the total number of enterade® drinks consumed
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 (Phosphorous) At 8 weeks The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )
Differences in bloating At 8 weeks Measured by reported incidence of bloating before and after taking enterade®
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.
Incidents adverse events At 8 weeks NCI CTCAE version 5.0
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®
Changes in weight At 8 weeks Measured by fluctuation in weight before and after taking enterade®
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 (Magnesium) At 8 weeks The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )
Differences in intravenous fluid requirements At 8 weeks Measured by the number of incidence requiring intravenous fluid before and after taking enterade®
Differences in flatulence At 8 weeks Measured by reported incidence of flatulence before and after taking enterade®
Trial Locations
- Locations (1)
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States