The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer|
- Efficacy in treatment of diarrhea [ Time Frame: 1 week ] [ Designated as safety issue: No ]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.
- Functional impact of CASAD [ Time Frame: 1 week ] [ Designated as safety issue: No ]To explore the functional impact of CASAD and the relative impact of diarrhea in relation to other symptom issues using MDASI-THY (M.D. Anderson Symptom Inventory-Thyroid, appendix D)
- Effect on thyroid function tests [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption
- Changes in MDASI-THY scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]To examine changes in MDASI-THY scores after treatment with CASAD
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
CASAD is provided in 500mg capsules.
Other Name: Calcium Aluminosilicate Anti-Diarrheal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739634
|Contact: Maria E Cabanillas, MDfirstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Maria E Cabanillas, MD|
|Sub-Investigator: Ramona Dadu, MD|