Cancer | CASAD for Severe Diarrhea in the Emergency Department
Cancer research study
What is the primary objective of this study?
The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can help to stop your diarrhea. Researchers also want to know if this drug can help decrease the duration of your diarrhea. In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study drug to learn if the study drug has any real effect.
Who is eligible to participate?
Inclusion Criteria: 1. Cancer patients presenting to the EC or an acute care clinic for NCI grade >/= 2 diarrhea 2. Able to understand the description of the study and give informed consent 3. Patients must be willing to and capable of providing frequent assessments for the duration of the study 4. English-speaking Exclusion Criteria: 1. Patients will not be approached while they have : a) evidence of fever or severe abdominal pain, melena, overt blood in stool; b) any clinical suspicion or evidence of peritonitis or bowel perforation; c) s/p allogenic stem cell transplant 2. Patients will not be approached if the EC physician thinks that the diarrhea is due to Crohn's disease, ulcerative colitis, Celiac disease, graft-versus-host disease, short-gut syndrome, neuroendocrine paraneoplastic syndromes (e.g., MEN, VIPomas, etc.), or malabsorption syndromes 3. Patients who are status post stem cell transplantation (both autologous or allogenic) 4. Patients who are status post immunotherapy (including those who are receiving or have received ipilimumab) 5. Patients participating in other clinical trials for diarrhea 6. Patients with a known allergy to any components of the CASAD formulation 7. Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications 8. Patients who cannot comply with medications 9. Patients taking any clay products 10. Patients with radiological evidence of megacolon, intraperitoneal free air, pneumatosis intestinalis, or fecal impaction 11. History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up 12. Patients who are pregnant 13. Patients less than 18 years of age
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Calcium Alumina-Silicate (CASAD)1 gram by mouth every 6 hours for up to 6 days.
Other:Placebo1 by mouth every 6 hours for up to 6 days.
Behavioral:QuestionnaireQuestionnaire completion at baseline about diarrhea and other symptoms.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Calcium Alumina-Silicate (CASAD)CASAD 1 gram by mouth every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
Placebo1 by mouth every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
Start Date: December 2013
Primary Outcome: Time to Resolution of Diarrhea (TTRD)
Study sponsors, principal investigator, and references
Principal Investigator: Sai-Ching J. Yeung, MD,PHD
Lead Sponsor: M.D. Anderson Cancer Center
Collaborator: Salient Pharmaceuticals Incorporated