CancerNCT02018653
CASAD for Severe Diarrhea in the Emergency Department
A study testing Calcium Alumina-Silicate (CASAD) and Questionnaire in people with Cancer and Diarrhea, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Calcium Alumina-Silicate (CASAD) and Questionnaire
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients presenting to the EC or an acute care clinic for NCI grade >/= 2 diarrhea
- Able to understand the description of the study and give informed consent
- Patients must be willing to and capable of providing frequent assessments for the duration of the study
- English-speaking
Who cannot join
- 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
- 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
- Patients who are status post stem cell transplantation (both autologous or allogenic)
- Patients who are status post immunotherapy (including those who are receiving or have received ipilimumab)
- Patients participating in other clinical trials for diarrhea
- Patients with a known allergy to any components of the CASAD formulation
Show all 13Show fewer
- Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications
- Patients who cannot comply with medications
- Patients taking any clay products
- Patients with radiological evidence of megacolon, intraperitoneal free air, pneumatosis intestinalis, or fecal impaction
- History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up
- Patients who are pregnant
- Patients less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
Read the detailed description
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.
- Being tested
- Calcium Alumina-Silicate (CASAD), Placebo, Questionnaire
- Keywords
- Cancer, Diarrhea, Calcium Alumina-Silicate, CASAD, Calcium Aluminosilicate anti-diarrheal, Placebo, Sugar pill, Questionnaire, Survey
- Medical subject headings
- Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Alumina-Silicate (CASAD)Drug
Also called CASAD, Calcium Aluminosilicate anti-diarrheal
1 gram by mouth every 6 hours for up to 6 days.
PlaceboOther
Also called Sugar pill
1 by mouth every 6 hours for up to 6 days.
QuestionnaireBehavioural
Also called Survey
Questionnaire completion at baseline about diarrhea and other symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Alumina-Silicate (CASAD) | Experimental | CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms. Receives: Drug: Calcium Alumina-Silicate (CASAD); Behavioral: Questionnaire |
| Placebo | Placebo comparator | Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms. Receives: Other: Placebo; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Salient Pharmaceuticals Incorporated
- Responsible party
- Sponsor
- Investigators
- Sai-Ching J. Yeung, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018653
- Sponsor's protocol ID
- 2013-0452
- Other IDs
- NCI-2014-01027
- Status last verified
- Jul 2018
- First submitted
- 17 Dec 2013
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02018653
- Acronym / sponsor ID
- 2013-0452
- Keywords
- Cancer, Diarrhea, Calcium Alumina-Silicate, CASAD, Calcium Aluminosilicate anti-diarrheal, Placebo, Sugar pill, Questionnaire
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Salient Pharmaceuticals Incorporated
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Posted 26 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Alumina-Silicate (CASAD) | Experimental | Drug: Calcium Alumina-Silicate (CASAD), Behavioral: QuestionnaireCASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms. |
| Placebo | Placebo comparator | Other: Placebo, Behavioral: QuestionnairePlacebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients presenting to the EC or an acute care clinic for NCI grade >/= 2 diarrhea
- Able to understand the description of the study and give informed consent
- Patients must be willing to and capable of providing frequent assessments for the duration of the study
- English-speaking
Key exclusion criteria (13 listed)
- 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
- 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
- Patients who are status post stem cell transplantation (both autologous or allogenic)
- Patients who are status post immunotherapy (including those who are receiving or have received ipilimumab)
- Patients participating in other clinical trials for diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Alumina-Silicate (CASAD)Also: CASAD, Calcium Aluminosilicate anti-diarrheal1 gram by mouth every 6 hours for up to 6 days. | Drug | Calcium Alumina-Silicate (CASAD) |
| PlaceboAlso: Sugar pill1 by mouth every 6 hours for up to 6 days. | Other | Placebo |
| QuestionnaireAlso: SurveyQuestionnaire completion at baseline about diarrhea and other symptoms. | Behavioural | Calcium Alumina-Silicate (CASAD), Placebo |
Primary outcome
Time to Resolution of Diarrhea (TTRD)
Time frame: 6 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai-Ching J. Yeung, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Alumina-Silicate (CASAD) and Questionnaire in people with Cancer and Diarrhea, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of Diarrhea (TTRD) (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.