The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

Phase 1

• Conditions: Diarrhea; Medullary Thyroid Cancer
• Interventions: Drug: CASAD

• Registration Number: NCT01739634
• Lead Sponsor: Salient Pharmaceuticals Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Study First Posted: 2012-12-03
• Last Update Posted: 2012-12-03
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Drug	CASAD	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.

Primary Outcome Measures

Name	Time	Method
Efficacy in treatment of diarrhea	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.

Secondary Outcome Measures

Name	Time	Method
Functional impact of CASAD	1 week	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	1 week	To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption
Changes in MDASI-THY scores	1 week	To examine changes in MDASI-THY scores after treatment with CASAD

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States