The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
Conditions
Diarrhea - Medullary Thyroid Cancer
Conditions: official terms
Diarrhea - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Diarrhea, Medullary thyroid cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CASAD
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)
Location
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
November 2012
Completion Date
December 2013
Sponsors
Salient Pharmaceuticals Incorporated
Source
Salient Pharmaceuticals Incorporated
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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