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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CASAD | Drug | CASAD is provided in 500mg capsules. |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria E Cabanillas, MD | Contact | mcabani@mdanderson.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018278 | Carcinoma, Neuroendocrine |
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| ID | Term |
|---|---|
| D000077250 | Calcium Aluminosilicate |
| ID | Term |
|---|---|
| D000538 | Aluminum Silicates |
| D000537 | Aluminum Oxide |
| D017607 | Aluminum Compounds |
| D007287 | Inorganic Chemicals |
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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 |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D017640 |
| Silicates |
| D008903 | Minerals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D012824 | Silicic Acid |
| D012822 | Silicon Dioxide |
| D017655 | Silicon Compounds |