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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Salient Pharmaceuticals Incorporated
Sponsor:
Information provided by (Responsible Party):
Salient Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01739634
First received: November 29, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diarrhea
Medullary Thyroid Cancer
Drug: CASAD
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Salient Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10
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)
Arms Assigned Interventions
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 Name: Calcium Aluminosilicate Anti-Diarrheal.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739634

Contacts
Contact: Maria E Cabanillas, MD mcabani@mdanderson.org

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Maria E Cabanillas, MD         
Sub-Investigator: Ramona Dadu, MD         
Sponsors and Collaborators
Salient Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Salient Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01739634     History of Changes
Other Study ID Numbers: SAL 2012-0584
Study First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Salient Pharmaceuticals Incorporated:
Diarrhea
Medullary thyroid cancer

Additional relevant MeSH terms:
Diarrhea
Thyroid Diseases
Thyroid Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014