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CASAD for Severe Diarrhea in the Emergency Department

Primary Purpose

Cancer, Diarrhea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calcium Alumina-Silicate (CASAD)
Placebo
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Diarrhea, Calcium Alumina-Silicate, CASAD, Calcium Aluminosilicate anti-diarrheal, Placebo, Sugar pill, Questionnaire, Survey

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcium Alumina-Silicate (CASAD)

Placebo

Arm Description

CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.

Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2013
Last Updated
July 24, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Salient Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02018653
Brief Title
CASAD for Severe Diarrhea in the Emergency Department
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Salient Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Diarrhea
Keywords
Cancer, Diarrhea, Calcium Alumina-Silicate, CASAD, Calcium Aluminosilicate anti-diarrheal, Placebo, Sugar pill, Questionnaire, Survey

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium Alumina-Silicate (CASAD)
Arm Type
Experimental
Arm Description
CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
Intervention Type
Drug
Intervention Name(s)
Calcium Alumina-Silicate (CASAD)
Other Intervention Name(s)
CASAD, Calcium Aluminosilicate anti-diarrheal
Intervention Description
1 gram by mouth every 6 hours for up to 6 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
1 by mouth every 6 hours for up to 6 days.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
Questionnaire completion at baseline about diarrhea and other symptoms.
Primary Outcome Measure Information:
Title
Time to Resolution of Diarrhea (TTRD)
Description
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.
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sai-Ching J. Yeung, MD,PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

CASAD for Severe Diarrhea in the Emergency Department

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