Cancer Clinical Trial
Official title:
A Double-Blinded Placebo-Controlled Pilot Trial of Calcium Alumina-Silicate (CASAD) in the Treatment of Severe Diarrhea (Grade 3 or 4) in Cancer Patients Presenting for Emergency Care
Verified date | July 2018 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Salient Pharmaceuticals Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Resolution of Diarrhea (TTRD) | The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days. | 6 days |
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