Pragmatic test of amino acid mixture/enterade® for Gastrointestinal Toxicity in Cancer therapy.
Constantine Mantz, MD, 21st Century Oncology, Fort Myers, FL
Institution: 21st Century Oncology (complete)
Title: Pragmatic test of amino-acid mixture/enterade® for Gastrointestinal Toxicity in Cancer Therapy.
Sample Size: 155 subjects.
Primary Objective: Determine if consumption of enterade® reduced diarrhea and other symptoms of gastrointestinal toxicity in cancer patients receiving radiotherapy and/or chemotherapy.
Primary Endpoint: Composite response for Nausea, Diarrhea, vomiting, oral mucositis, bloating and cramping or any type of radiotherapy and or chemotherapy secondary adverse effect (weight maintenance, dehydration, malaise). Patient reported improvement in: diarrhea, dehydration, nausea, fatigue, oral mucositis.
Secondary Endpoints: Safety, tolerability, compliance.
Data on File
A Randomized Double-Blinded Phase 2 Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma
Brett Glotzbecker, MD, Robert J. Soiffer, MD, Dana Farber Cancer Institute/Brigham and Women’s Hospital, Boston, MA and Mounica Vallurupalli, MD, Brigham and Women’s Hospital, Boston MA
Gastrointestinal Cancer Symposium Poster Presentation
enterade® and its MOA have been extensively reviewed in published research. The following papers are available online for your review. Check back often, as this page will be updated with the most current clinical research.
- Enterade Featured in NSBRI Forum
- A Potent Amino Acid Mixture to Mitigate Radiation-Induced Gastrointestinal Toxicity – Health Physics Journal
- Glucose stimulates calcium-activated chloride secretion in small intestinal cells – American Journal of Physiology
- Irradiation decreases SGLT1 mediated glucose absorption – Page 129 – Radiation Research Society Abstracts of 56th Annual Meeting
- Barrier function of mouse small intestinal mucosa alters with irradiation dose – Page 120 – Radiation Research Society Abstracts of 56th Annual Meeting
- Paracellular ion selectivity parallels loss of mucosal barrier following irradiation
- Radiation decreases murine small intestinal HCO3- secretion – International Journal of Radiation Biology
- Acute inflammation alters bicarbonate transport in mouse ileum – Journal of Physiology
- Fibroblast growth factor-peptide improves barrier function and proliferation in human keratinocytes after radiation – International Journal of Radiation Oncology * Biology * Physics
- NOD2 gene mutation improves mucosal function and increases survival in irradiated mice – Gastroenterology
- Effects of butyrate on active sodium and chloride transport in rat and rabbit distal colon – Journal of Physiology
Significant advancement in Supportive Care for Cancer Patients published in Nature.
November 23rd, 2016
Space Institute funded study shows that enterade® Advance Oncology (amino acid-based oral rehydration solution) increased villus height and improved electrolyte and nutrient absorption in irradiated mice.
Entrinsic Health Solutions, Inc., an innovative health sciences company announced the publication of results from research at the University of Florida using enterade® Advanced Oncology (AO) formulation titled, “An amino acid-based oral rehydration solution (AA-ORS) enhanced intestinal epithelial proliferation in mice exposed to radiation.” The full article can be found in the 23 November, 2016 issue of Nature at www.nature.com/articles/srep37220. The article is also available in the News & Media section of the Entrinsic Health Solutions website at www.entrinsichealth.com.