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
Glucose enhances rotavirus enterotoxin-induced intestinal chloride secretion – Read More
Entrinsic Health Solutions Announces Positive Top Line Clinical Trial Results in Retrospective Study of enterade ® – Read More
Entrinsic Health Solutions Announces Data from Poster Presentation at ISSN Annual Meeting- Read More
Entrinsic Health Solutions Announces Data from Poster Presentation at MASCC Annual Meeting- Read More
Researchers Learn More About Drink That Aids Post-Radiation Recovery – Read More
The select amino acids provided by enterade® help facilitate the hydration needed due to the electrolyte imbalance caused by GI dysfunction.
Publications
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.
- Entrinsic Health Solutions and Markey Cancer Center Present Clinical Data in Patients with Neuroendocrine Tumors at the 2018 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
- Entrinsic Health Solutions and Markey Cancer Center Present Clinical Data in Patients with Neuroendocrine Tumors at the 2018 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
- 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