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

NCT01739634 | Unknown Phase 1 DMC

• 1 other identifier: SAL 2012-0584
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Medullary Thyroid Cancer

Keywords

Diarrhea; Medullary thyroid cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional impact of CASAD

  1 week

• Effect on thyroid function tests

  1 week

• Changes in MDASI-THY scores

  1 week

Study Arms (1)

Active Drug

EXPERIMENTAL

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

Interventions

CASAD DRUG

CASAD is provided in 500mg capsules.

Also known as: Calcium Aluminosilicate Anti-Diarrheal.

Active Drug

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Salient Pharmaceuticals Incorporated: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Diarrhea; Carcinoma, Medullary

Interventions

Calcium Aluminosilicate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Aluminum Silicates; Aluminum Oxide; Aluminum Compounds; Inorganic Chemicals; Silicates; Minerals; Oxides; Oxygen Compounds; Silicic Acid; Silicon Dioxide; Silicon Compounds

Central Study Contacts

Maria E Cabanillas, MD

CONTACT

mcabani@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

US (1)