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.

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