Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 4:16 AM
Study NCT ID:
NCT01739634
Status:
UNKNOWN
Last Update Posted:
2012-12-03
First Post:
2012-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077250', 'term': 'Calcium Aluminosilicate'}], 'ancestors': [{'id': 'D000538', 'term': 'Aluminum Silicates'}, {'id': 'D000537', 'term': 'Aluminum Oxide'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017640', 'term': 'Silicates'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D012824', 'term': 'Silicic Acid'}, {'id': 'D012822', 'term': 'Silicon Dioxide'}, {'id': 'D017655', 'term': 'Silicon Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in treatment of diarrhea', 'timeFrame': '1 week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Functional impact of CASAD', 'timeFrame': '1 week', 'description': '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)'}, {'measure': 'Effect on thyroid function tests', 'timeFrame': '1 week', 'description': 'To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption'}, {'measure': 'Changes in MDASI-THY scores', 'timeFrame': '1 week', 'description': 'To examine changes in MDASI-THY scores after treatment with CASAD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diarrhea', 'Medullary thyroid cancer'], 'conditions': ['Diarrhea', 'Medullary Thyroid Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with medullary thyroid cancer\n* Men and women from all ethnic and racial groups\n* Diarrhea ( \\>=3 loose bowel movements per day)\n* Duration of diarrhea of at least 1 week\n\nExclusion Criteria:\n\n* Patients with MEN 2b (since these patients may have megacolon)\n* Patients taking any clay products\n* History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.\n* Patients who cannot comply with medications\n* Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.\n* Pregnancy or lactation\n* Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)'}, 'identificationModule': {'nctId': 'NCT01739634', 'briefTitle': 'The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Salient Pharmaceuticals Incorporated'}, 'officialTitle': 'The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer', 'orgStudyIdInfo': {'id': 'SAL 2012-0584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Drug', 'description': '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.', 'interventionNames': ['Drug: CASAD']}], 'interventions': [{'name': 'CASAD', 'type': 'DRUG', 'otherNames': ['Calcium Aluminosilicate Anti-Diarrheal.'], 'description': 'CASAD is provided in 500mg capsules.', 'armGroupLabels': ['Active Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria E Cabanillas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ramona Dadu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Maria E Cabanillas, MD', 'role': 'CONTACT', 'email': 'mcabani@mdanderson.org'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salient Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}