Clinical trial · Interventional
CASAD for Severe Diarrhea in the Emergency Department
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diarrhea | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium Alumina-Silicate (CASAD) | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Calcium Alumina-Silicate (CASAD)
- description
- CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
- interventionNames
- Drug: Calcium Alumina-Silicate (CASAD)
- Behavioral: Questionnaire
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
- interventionNames
- Other: Placebo
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Time to Resolution of Diarrhea (TTRD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available