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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
11
Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Change in bowel movement frequency
Changes in number of average daily bowel movements from baseline
Time frame: At 8 weeks
Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0
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.
Time frame: At 8 weeks
Tolerability of enterade®: number of enterade® drinks consumed
Measured by the total number of enterade® drinks consumed
Time frame: At 8 weeks
Incidents adverse events
NCI CTCAE version 5.0
Time frame: At 8 weeks
Change in serum electrolytes (Sodium)
The electrolyte sodium will be assessed for each patient before and after enterade® (measured in mmol/L)
Time frame: At 8 weeks
Change in serum electrolytes (Potassium)
The electrolyte potassium will be assessed for each patient before and after enterade® (measured in mmol/L)
Time frame: At 8 weeks
Change in serum electrolytes (Chloride)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The electrolyte chloride will be assessed for each patient before and after enterade® (measured in mmol/L)
Time frame: At 8 weeks
Change in serum electrolytes (Magnesium)
The electrolyte magnesium will be assessed for each patient before and after enterade® (measured in mg/dL )
Time frame: At 8 weeks
Change in serum electrolytes (Phosphorous)
The electrolyte phosphorous will be assessed for each patient before and after enterade® (measured in mg/dL )
Time frame: At 8 weeks
Differences in intravenous fluid requirements
Measured by the number of incidence requiring intravenous fluid before and after taking enterade®
Time frame: At 8 weeks
Differences in use of standard-of-care anti-diarrhea medications
Measured by reported incidence of standard-of-care anti-diarrhea medications usage before and after taking enterade®
Time frame: At 8 weeks
Differences in bloating
Measured by reported incidence of bloating before and after taking enterade®
Time frame: At 8 weeks
Differences in flatulence
Measured by reported incidence of flatulence before and after taking enterade®
Time frame: At 8 weeks
Changes in weight
Measured by fluctuation in weight before and after taking enterade®
Time frame: At 8 weeks