evaluating an amino acid based medical food w/ diarrhea in carcinoid syndrome & other nets

Conditions: Neuroendocrine Tumors; Carcinoid Tumor of GI System; Diarrhea; Carcinoid Syndrome

Summary: primary objective: to assess how an amino acid based medical food (enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to neuroendocrine tumors (net) and/or carcinoid syndrome. this improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving enterade®. each subject serves as his or her own control. secondary objectives: * to assess subject reported health-related quality of life in subjects before and after compound administration. * to characterize the side effect profile and tolerability of enterade® as measured by the number of total 8-oz enterade® bottles consumed throughout the trial, and average drinks per day. * to evaluate changes in serum electrolytes before and after administration of eenterade®. * to assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active enterade® period. * to evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and enterade® period. * to compare subjective feeling of bloating and flatulence before and after administration of enterade®. * to evaluate changes in patient weight before and after administration of enterade®.

this prospective, phase 2 study is to assess how enterade® will affect patient-reported quality of life and intestinal absorption in patients with carcinoid syndrome and neuroendocrine tumors. the hypothesis is that enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency. * this is a non-randomized, supportive-care study. * potentially eligible patients will be screened in the university of kentucky markey cancer center clinics. * during the screening visit, immediately after signing informed consent, the participant will be given both flavors of enterade® (original vanilla and refreshing orange) to test tolerability and taste. * eligible subjects will be given a stool diary and will be asked to document daily stool output (frequency and consistency of stool), use of anti-diarrheal medication and gastrointestinal discomforts (bloating, cramping). * all lab and screening tests should be completed within 2 weeks prior to registration/initiation of study. * the study is broken into 3 distinct segments and will apply to all enrolled participants: baseline observation (weeks 1-4), enterade® administration period (4 weeks), post-enterade® period (4 weeks). * after relapse of diarrhea is documented or the 4 weeks of post-enterade® observation are completed (whatever happens first), participants will be given the option to restart enterade® for 1 additional month.

Eligibility criteria:
inclusion criteria: * cohort 1: participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), and an elevated serum serotonin or plasma serotonin above the upper limit of normal per reference lab. * cohort 2: 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 and telotristat), but are below the cut-point for serotonin elevation. * age equal to or greater than 18 years old. * 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 active clostridium difficile infection will be ineligible for this study. * 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 12 months.

Keywords: enterade medical food/drink