Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 08/25/2019 |
| Estimated Enrollment Submitted: | 08/26/2019 |
| First Posted: | 08/27/2019 |
| Last Update Submitted: | 07/13/2020 |
| Last Update Posted: | 07/14/2020 |
| Actual Study Start Date: | 11/03/2019 |
| Estimated Primary Completion Date: | 03/31/2021 |
| Estimated Study Completion Date: | 03/31/2022 |
Condition or disease
Intervention/treatment
Dietary Supplement: Enterade®
Other: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Change in bowel movement frequency [At 8 weeks]
Secondary Outcome Measures
1. Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0 [At 8 weeks]
2. Tolerability of enterade®: number of enterade® drinks consumed [At 8 weeks]
3. Incidents adverse events [At 8 weeks]
4. Change in serum electrolytes (Sodium) [At 8 weeks]
5. Change in serum electrolytes (Potassium) [At 8 weeks]
6. Change in serum electrolytes (Chloride) [At 8 weeks]
7. Change in serum electrolytes (Magnesium) [At 8 weeks]
8. Change in serum electrolytes (Phosphorous) [At 8 weeks]
9. Differences in intravenous fluid requirements [At 8 weeks]
10. Differences in use of standard-of-care anti-diarrhea medications [At 8 weeks]
11. Differences in bloating [At 8 weeks]
12. Differences in flatulence [At 8 weeks]
13. Changes in weight [At 8 weeks]
