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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01739634
• Other study ID #: SAL 2012-0584
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 29, 2012
• Last updated: November 29, 2012
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2012
• Source: Salient Pharmaceuticals Incorporated
• Contact: Maria E Cabanillas, MD
• Email: mcabani[@]mdanderson.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Medullary Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• CASAD
CASAD is provided in 500mg capsules.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Salient Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in treatment of diarrhea	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.	1 week	No
Secondary	Functional impact of CASAD	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)	1 week	No
Secondary	Effect on thyroid function tests	To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption	1 week	Yes
Secondary	Changes in MDASI-THY scores	To examine changes in MDASI-THY scores after treatment with CASAD	1 week	No