This phase II trial studies how well a medical food called enterade works in reducing bowel movement frequency in patients with neuroendocrine tumor. is a commercially available amino acid-based medical food being developed to manage diarrhea due to neuroendocrine tumors either directly (carcinoid syndrome) or indirectly (non-carcinoid syndrome). It may also alleviate abdominal pain or discomfort, bloating, cramping and gas secondary to the disease. Enterade may alleviate neuroendocrine tumor associated diarrhea, provide control of bowel-related symptoms, and improve quality of life in neuroendocrine tumor patients with diarrhea.
Additional locations may be listed on ClinicalTrials.gov for NCT04073017.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the ability of amino acid/electrolyte mixture-based dietary supplement (enterade) to reduce bowel movement frequency in neuroendocrine tumor (NET) patients.
SECONDARY OBJECTIVES:
I. To assess subject-reported health-related quality of life measures in subjects before and after compound administration. (Functional Assessment of Chronic Illness Therapy-Diarrhea [FACIT-D], version 4, D. Cella et al.)
II. 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.
III. To evaluate changes in serum electrolytes before and after administration of the compound.
IV. To assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade period.
V. To evaluate differences in utilization of standard-of-care anti-diarrheal medications in patients between observation period and enterade period.
VI. To compare subjective bloating and flatulence in patients before and after administration of the compound.
VII. To evaluate changes in patient weight before and after administration of the compound.
EXPLORATORY OBJECTIVES:
I. To assess changes in serum and stool inflammatory markers (IL-1beta, IL-6 and tumor necrotic factor [TNF]alpha and serum endotoxin) before and after the study compound.
II. To evaluate changes in fecal lactoferrin before and after study compound administration.
OUTLINE:
OBSERVATION PERIOD: Patients are clinically observed for bowel movement frequency during weeks 1-4.
INTERVENTION PERIOD: Patients receive enterade orally (PO) twice daily (BID) during weeks 5-8 in the absence of disease progression or unacceptable toxicity.
After completion of study intervention, patients are followed up as per their treating oncologist’s discretion.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorSatya Das
