Entrinsic Health Solutions and Markey Cancer Center Launch
December 12th, 2018
Clinical Trial to Assess How enterade® Helps Retain Fluids and Reduce Diarrhea in
Carcinoid Syndrome and Neuroendocrine Tumor Patients
NORWOOD, Mass., December 12, 2018 – Entrinsic Health Solutions in partnership with the University of Kentucky (UK) Markey Cancer Center today announced initiation of active accrual and first consented patient in its Phase II study evaluating enterade® – a glucose-free, medical food – in neuroendocrine tumor and carcinoid syndrome patients. Findings from this study may show that enterade can help maintain the small bowel’s ability to retain fluids leading to a reduction in stool frequency. The study will also examine the effects of enterade on patient-reported gastrointestinal symptoms and quality of life.
“One of the most debilitating symptoms as a result of neuroendocrine tumors is chronic diarrhea, which occurs in about 78% of patients with carcinoid syndrome. Moreover, despite the high prevalence of severe diarrhea in this population, there are limited nutritional options for patients,” said Lowell B. Anthony, MD, FACP, Principal Investigator and Chief, Division of Medical Oncology at UK Markey Cancer Center. “By delivering distinct nutritional requirements, we hypothesize that enterade can restore electrolyte imbalance, and in turn, alleviate gastrointestinal symptoms related to neuroendocrine tumors, like diarrhea.”
“In our previous pilot study, enterade was shown to be quite effective in reducing stool frequency and improving the quality of life of patients who took the product for as little as 10 days,” said Stephen Gatto, Chairman and CEO for Entrinsic Health Solutions. “Our expectation is that this carefully designed Phase II study will provide the necessary validation to support enterade’s broad use as a front line supportive care approach to addressing the negative side effects due to neuroendocrine tumors and carcinoid syndrome.”
Leveraging the power of amino acids, oncologists and gastroenterologists developed enterade to actively address the distinct changes to the gastrointestinal tract during cancer treatment which impact absorption, digestion and immune function.
For the study, two distinct patient cohorts will be enrolled: carcinoid syndrome diarrhea and non-carcinoid syndrome diarrhea. The primary endpoint is restoration of gut health by improving intestinal absorption and reduction in frequency of diarrhea. Weeks 1-4 will be an observation period to assess baseline stool output. During weeks 5-8, eligible patients will drink two bottles of enterade each day. After this point, patients will be off enterade and observed for four weeks.
For more information on the study, please visit ClinicalTrials.gov (ID: NCT:03722511).
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