Efficacy of the Natural Clay, Calcium Aluminosilicate Anti-Diarrheal, in Reducing Medullary Thyroid Cancer–Related Diarrhea and Its Effects on Quality of Life: A Pilot Study

作者：Ramona Dadu, Mimi I-Nan Hu, Charles S. Cleeland, Naifa Lamki Busaidy, Mouhammed Amir Habra, Steven Gerard Waguespack, Steven I. Sherman, Anita Kuo Ying, Patricia S. Fox, Maria E. Cabanillas · 发表于：Thyroid · 年份：2015 · DOI：10.1089/thy.2015.0166 · 被引用次数：23 · 研究领域：Therapeutic Uses of Natural Elements、Clay minerals and soil interactions、Occupational and environmental lung diseases

INTRODUCTION: Medullary thyroid cancer (MTC)-related diarrhea can be debilitating, reduces quality of life (QOL), and may be the only indication for initiating systemic therapy. Conventional antidiarrheal drugs are not always helpful and may have side effects. Calcium aluminosilicate antidiarrheal (CASAD), a natural calcium montmorrilonite clay, safely adsorbs toxins and inflammatory proteins associated with diarrhea. It was hypothesized that CASAD would reduce the severity of diarrhea and improve QOL in MTC patients. METHODS: This was a prospective pilot trial (NCT01739634) of MTC patients not on systemic therapy with self-reported diarrhea of three or more bowel movements (BMs) per day for a week or more. The study design included a one-week run-in period followed by one week of CASAD ± a two-week optional continuation period. The primary endpoint was efficacy of one week of CASAD treatment in decreasing the number of BMs per day by ≥20% when compared with the baseline run-in period. Secondary objectives included tolerability and safety and the impact on QOL using the MD Anderson Symptom Inventory-Thyroid questionnaire (MDASI-THY). RESULTS: Ten MTC patients (median age = 52 years, 70% female, 80% white) were enrolled. All had distant metastases, and median calcitonin was 5088 ng/mL (range 1817-42,007 ng/mL). Ninety percent had received prior antidiarrheals, and 40% of these had used two or more drugs, including tincture of opium (30%), loperamide (50%), diphenoxylate/atropi...