CASAD for Severe Diarrhea in the Emergency Department
Sleutelwoorden
Abstract
Omschrijving
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either CASAD orally or a placebo. You will have an equal chance of being assigned to either group.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Treatment:
You take either CASAD or placebo by mouth every 6 hours with about 1 cup (8 oz.) of water. You will also be given other supportive care and treatment for diarrhea (such as imodium and lomotil).
You will be asked to keep a journal, which includes a record of the time you take the study drug each day and a history of your bowel movements every day you take CASAD or placebo.
Study Visits:
Before the dose:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be recorded.
- You will be asked when your diarrhea started.
- You will be asked about any drugs you have taken for the cancer and diarrhea.
- A stool sample will be collected to test for toxins.
- Blood (about 1 teaspoon) will be drawn to measure cytokines (proteins that may affect the immune system and inflammation) .
- You will be asked about your diarrhea and other symptoms. It should take about 5 minutes to answer these questions.
At the same visit after the dose:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about your diarrhea.
- You will be asked if you have any side effects.
On Day 1 (the day after your visit to the Emergency Center):
-Blood (about 1 teaspoon) will be drawn to check your electrolytes and to measure cytokines and inflammation (optional).
On Days 2-6 (this will be by phone or the staff will visit you if you are in the hospital):
- You will be asked about your diarrhea.
- You will be asked if you have any side effects.
Length of Treatment:
You will take the study drug or placebo for up to 6 days or when the diarrhea stops, whichever happens first. You will no longer be able to take the study drug or placebo if the diarrhea gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Follow-Up:
After you are off study, the study nurse will call you and ask if you have had any other side effects since finishing the study treatment. The phone call should only last about 5 minutes. If you are still an inpatient at the hospital, the study nurse may visit you and ask you these questions in person.
At your next scheduled appointment at MD Anderson, the nurse will meet with you to get your final journal and any unused study drug. If you do not return to MD Anderson, you will receive a self-addressed stamped envelope for you to return this information.
This is an investigational study. CASAD is FDA approved as a food additive, but it has not been approved to treat a disease. Its use to treat diarrhea is investigational.
Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.
Datums
| Laatst geverifieerd: | 06/30/2018 |
| Eerste ingediend: | 12/16/2013 |
| Geschatte inschrijving ingediend: | 12/16/2013 |
| Eerst geplaatst: | 12/22/2013 |
| Laatste update ingediend: | 07/23/2018 |
| Laatste update geplaatst: | 07/25/2018 |
| Datum van eerste ingediende resultaten: | 11/04/2015 |
| Datum van eerste ingediende QC-resultaten: | 07/23/2018 |
| Datum van eerste geposte resultaten: | 07/25/2018 |
| Werkelijke startdatum van het onderzoek: | 11/30/2013 |
| Geschatte primaire voltooiingsdatum: | 07/31/2014 |
| Geschatte voltooiingsdatum van het onderzoek: | 07/31/2014 |
Conditie of ziekte
Interventie / behandeling
Drug: Calcium Alumina-Silicate (CASAD)
Other: Placebo
Behavioral: Questionnaire
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Calcium Alumina-Silicate (CASAD) CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms. | Drug: Calcium Alumina-Silicate (CASAD) 1 gram by mouth every 6 hours for up to 6 days. |
| Placebo Comparator: Placebo Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms. | Other: Placebo 1 by mouth every 6 hours for up to 6 days. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | 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 |
Resultaat
Primaire uitkomstmaten
1. Time to Resolution of Diarrhea (TTRD) [6 days]
