Abstract | INTRODUCTION: 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/ atropine (20%), colestipol (10%), or cholestyramine (10%). Of seven evaluable patients, four (56%) had ≥20% reduction in BMs per day. Six out of seven patients discontinued their prior antidiarrheals. Best response ranged from 7% to 99% reduction in mean BMs/day from baseline. Five out of seven patients considered CASAD a success, and they opted for the two-week continuation period. Improvements in diarrhea and all six interference items assessed by MDASI-THY were noted at weeks 1 and 3. Total interference score was significantly improved at three weeks compared with baseline (p = 0.05). An oral levothyroxine absorption test was performed in one patient; malabsorption of levothyroxine was not observed. Adverse events included flatulence (40%), bloating (10%), heartburn (10%), and constipation (10%). CONCLUSIONS:
CASAD is a promising strategy for treatment of MTC-related diarrhea. In this small pilot study, improvements in frequency and quality of diarrhea as well as QOL were noted. Further studies in this population are warranted.
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Authors | Ramona Dadu, Mimi I Hu, Charles Cleeland, Naifa L Busaidy, Mouhammed Habra, Steven G Waguespack, Steven I Sherman, Anita Ying, Patricia Fox, Maria E Cabanillas |
Journal | Thyroid : official journal of the American Thyroid Association
(Thyroid)
Vol. 25
Issue 10
Pg. 1085-90
(Oct 2015)
ISSN: 1557-9077 [Electronic] United States |
PMID | 26200040
(Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aluminum Silicates
- Antidiarrheals
- Clay
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Topics |
- Adult
- Aged
- Aluminum Silicates
(therapeutic use)
- Antidiarrheals
(therapeutic use)
- Carcinoma, Medullary
(complications)
- Clay
- Diarrhea
(drug therapy, etiology)
- Female
- Humans
- Male
- Middle Aged
- Pilot Projects
- Prospective Studies
- Quality of Life
- Thyroid Neoplasms
(complications)
- Treatment Outcome
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