Clinical trial NCT04073017: Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Official title: Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuroendocrine Tumor
Carcinoid Syndrome
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Entrinsic Bioscience Inc.
First posted: 2019-08-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in bowel movement frequency
timeFrame: At 8 weeks
Secondary outcomes:
measure: Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0
timeFrame: At 8 weeks
measure: Tolerability of enterade®: number of enterade® drinks consumed
timeFrame: At 8 weeks
measure: Incidents adverse events
timeFrame: At 8 weeks
measure: Change in serum electrolytes (Sodium)
timeFrame: At 8 weeks
measure: Change in serum electrolytes (Potassium)
timeFrame: At 8 weeks
measure: Change in serum electrolytes (Chloride)
timeFrame: At 8 weeks
measure: Change in serum electrolytes (Magnesium)
timeFrame: At 8 weeks
measure: Change in serum electrolytes (Phosphorous)
timeFrame: At 8 weeks
measure: Differences in intravenous fluid requirements
timeFrame: At 8 weeks
measure: Differences in use of standard-of-care anti-diarrhea medications
timeFrame: At 8 weeks
measure: Differences in bloating
timeFrame: At 8 weeks
measure: Differences in flatulence
timeFrame: At 8 weeks
measure: Changes in weight
timeFrame: At 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Satya Das, MD
role: PRINCIPAL_INVESTIGATOR
References: