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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Time to Resolution of Diarrhea (TTRD)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Calcium Alumina-Silicate (CASAD) (Drug)
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.
干预措施: Questionnaire (Behavioral)
Placebo
Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
干预措施: Placebo (Other)
Placebo
Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Time to Resolution of Diarrhea (TTRD)
时间窗: 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.
次要结局
未报告次要终点