Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea. This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg) of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently. In order to participate in this clinical trial, patients must be male or female 18 years of age or older. Inclusion into this investigational drug trial is based on the protocol entry criteria and a detailed evaluation from a participating trial investigator
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Kenmar Research Institute
Burbank, California, United States
Bay Area Cancer Research Group
Concord, California, United States
Compassionate Cancer Care medical Group, Inc.
Fountain Valley, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Pacific Shores Medical Center
Long Beach, California, United States
Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy
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Kenmar Research Institute
Los Angeles, California, United States
Oncology Hematology Group of South Florida
Miami, Florida, United States
Pasco Hernando Oncology Associates
New Port Richey, Florida, United States
Mid-Florida Hematology & Oncology Centers, PA
Orange City, Florida, United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States
...and 24 more locations