The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Efficacy in treatment of diarrhea
研究概览
简要总结
Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with medullary thyroid cancer
- •Men and women from all ethnic and racial groups
- •Diarrhea ( >=3 loose bowel movements per day)
- •Duration of diarrhea of at least 1 week
排除标准
- •Patients with MEN 2b (since these patients may have megacolon)
- •Patients taking any clay products
- •History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
- •Patients who cannot comply with medications
- •Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
- •Pregnancy or lactation
- •Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)
研究组 & 干预措施
Active Drug
After a 1 week run-in period CASAD will be administered TID for 1 week. Each dose will be 2 500mg CASAD capsules. Patients will be followed for two weeks post active drug administration.
干预措施: CASAD (Drug)
结局指标
主要结局
Efficacy in treatment of diarrhea
时间窗: 1 week
To evaluate the efficacy of CASAD 3 grams per day in reducing the severity of diarrhea after 1 week of treatment in patients with MTC.
次要结局
- Functional impact of CASAD(1 week)
- Effect on thyroid function tests(1 week)
- Changes in MDASI-THY scores(1 week)