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 Overview

• Status: Unknown
• Conditions: Diarrhea; Medullary Thyroid Cancer
• Intervention / Treatment: Drug: CASAD

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Maria E Cabanillas, MD; Email: mcabani@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: Maria E Cabanillas, MD
      • Sub-Investigator: Ramona Dadu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: CASAD; CASAD is provided in 500mg capsules.; Other Names: Calcium Aluminosilicate Anti-Diarrheal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Effect on thyroid function tests	To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption	1 week
Changes in MDASI-THY scores	To examine changes in MDASI-THY scores after treatment with CASAD	1 week

Collaborators and Investigators

• Sponsor: Salient Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Diarrhea; Medullary thyroid cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Signs and Symptoms, Digestive; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Diarrhea; Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Neuroendocrine; Gastrointestinal Agents; Antidiarrheals; Calcium Aluminosilicate
• Other Study ID Numbers: SAL 2012-0584