Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT03688958
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine Supplementation on Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007455', 'term': 'Iodine'}], 'ancestors': [{'id': 'D006219', 'term': 'Halogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-12-01', 'size': 168798, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-08-31T18:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two randomized clinical groups including women with early (stage II) and advanced (stage III) breast cancer. In the Early group, women were treated with I2 (5 mg/day) or placebo (colored water) for 7 to 35 days. In the Advanced group, patients received treatment (I2 or placebo) along with 4 to 6 cycles of FEC/TE treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response [change in size]', 'timeFrame': '20 minutes', 'description': 'The size of the tumor is calculated by measuring the largest diameter of the tumor in the axial plane. The first measurement is obtained in the mammography taken before the start of the protocol and the second measurement is made on the tissue after surgery. The change percentage is obtained by dividing the final size between the initial size by 100.'}, {'measure': 'Incidence of treatment-emergent adverse events [Safety and Tolerability]).', 'timeFrame': '40 minutes', 'description': 'Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation)'}, {'measure': 'Differential Blood Count', 'timeFrame': '10 minutes (duration of blood withdrawal)]', 'description': 'Differential blood count gives relative percentage of each type of white blood cell and helps reveal abnormal white blood cell populations (eg, blasts, immature granulocytes, or circulating mature cells in the peripheral blood).'}, {'measure': 'Thyroid Test', 'timeFrame': '10 minutes (duration of blood withdrawal)', 'description': 'Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method'}, {'measure': 'Cardiac damage', 'timeFrame': '10 minutes (duration of blood withdrawal)', 'description': 'Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.'}, {'measure': 'Iodine consumes', 'timeFrame': '10 minutes (duration of urine recollection)', 'description': 'Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method.'}, {'measure': 'Tumor classification type and modification after treatment', 'timeFrame': '40 minutes', 'description': 'Estrogen receptor (ER), Progesterone receptor (PR) and Human epidermal growth factor receptor 2 (HER2) presence in biopsy (initial) and tumor sample after treatments (final) by immunohistochemical method (number of positive cells/field).'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'Every 6 months for 5 years', 'description': 'The follow-up of the disease-free survival (DFS) at 5 years. (patient interview and clinical auscultation each six months)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29530037', 'type': 'RESULT', 'citation': 'Zambrano-Estrada X, Landaverde-Quiroz B, Duenas-Bocanegra AA, De Paz-Campos MA, Hernandez-Alberto G, Solorio-Perusquia B, Trejo-Mandujano M, Perez-Guerrero L, Delgado-Gonzalez E, Anguiano B, Aceves C. Molecular iodine/doxorubicin neoadjuvant treatment impair invasive capacity and attenuate side effect in canine mammary cancer. BMC Vet Res. 2018 Mar 12;14(1):87. doi: 10.1186/s12917-018-1411-6.'}, {'pmid': '28901484', 'type': 'RESULT', 'citation': 'Bontempo A, Ugalde-Villanueva B, Delgado-Gonzalez E, Rodriguez AL, Aceves C. Molecular iodine impairs chemoresistance mechanisms, enhances doxorubicin retention and induces downregulation of the CD44+/CD24+ and E-cadherin+/vimentin+ subpopulations in MCF-7 cells resistant to low doses of doxorubicin. Oncol Rep. 2017 Nov;38(5):2867-2876. doi: 10.3892/or.2017.5934. Epub 2017 Sep 1.'}, {'pmid': '26376791', 'type': 'RESULT', 'citation': 'Nava-Villalba M, Nunez-Anita RE, Bontempo A, Aceves C. Activation of peroxisome proliferator-activated receptor gamma is crucial for antitumoral effects of 6-iodolactone. Mol Cancer. 2015 Sep 17;14:168. doi: 10.1186/s12943-015-0436-8.'}, {'pmid': '23705792', 'type': 'RESULT', 'citation': 'Alfaro Y, Delgado G, Carabez A, Anguiano B, Aceves C. Iodine and doxorubicin, a good combination for mammary cancer treatment: antineoplastic adjuvancy, chemoresistance inhibition, and cardioprotection. Mol Cancer. 2013 May 24;12:45. doi: 10.1186/1476-4598-12-45.'}, {'pmid': '23607319', 'type': 'RESULT', 'citation': 'Aceves C, Anguiano B, Delgado G. The extrathyronine actions of iodine as antioxidant, apoptotic, and differentiation factor in various tissues. Thyroid. 2013 Aug;23(8):938-46. doi: 10.1089/thy.2012.0579.'}, {'pmid': '15922087', 'type': 'RESULT', 'citation': 'Garcia-Solis P, Alfaro Y, Anguiano B, Delgado G, Guzman RC, Nandi S, Diaz-Munoz M, Vazquez-Martinez O, Aceves C. Inhibition of N-methyl-N-nitrosourea-induced mammary carcinogenesis by molecular iodine (I2) but not by iodide (I-) treatment Evidence that I2 prevents cancer promotion. Mol Cell Endocrinol. 2005 May 31;236(1-2):49-57. doi: 10.1016/j.mce.2005.03.001. Epub 2005 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The trial investigates the effect of oral supplement of molecular iodine (I2) alone and in combination with 4 to 6 cycles of FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) treatment in woman diagnosticated with early (stage II) and advance (stage III) breast cancer, respectively. The study analyzes the clinical response \\[tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)\\] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).', 'detailedDescription': 'The leading causes of failure of breast cancer treatment are the rapid development of metastases and tumor resistance to antineoplastic drugs. Anthracyclines (doxorubicin (DOX), epirubicin, etc.) are the golden standard in neoadjuvant therapy and are commonly used in the FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) combination therapy during advanced breast cancer. However, even when treated with this potent chemotherapeutic combination, 30% of patients develop chemoresistance and cardiomyopathic side effects. Previous studies support that the oral supplement of molecular iodine (I2) exerts synergistic antineoplastic and cardioprotective impact when used in combination with the DOX in rodent and canine mammary cancer model. The present study performed two randomized clinical groups including women with early (stage II) and advanced (stage III) breast cancer. In the Early group, women were treated with I2 (5 mg/day) or placebo (colored water) for 7 to 35 days. In the Advanced group, patients received treatment (I2 or placebo) along with 4 to 6 cycles of FEC/TE treatment. The study analyzes the clinical response \\[tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)\\] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, stage II or III breast cancer\n* Scheduled to surgical of the primary tumor (stage II)\n* Will receive neoadjuvant FEC/TE chemotherapy (stage III).\n* age \\> 18 and \\< 81 years\n* Non-pregnant\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Known sensitivity to iodine or FEC/TE\n* Concurrent severe and/or uncontrolled disease\n* Myocardial infarction within the last six months before the study\n* Unstable or uncontrolled hypertension\n* Thyroid dysfunction'}, 'identificationModule': {'nctId': 'NCT03688958', 'briefTitle': 'Iodine Supplementation on Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional Autonoma de Mexico'}, 'officialTitle': 'Effect of Dietary Iodine Supplementation on the Proliferation of Breast Cancer', 'orgStudyIdInfo': {'id': 'INB-UNAM-004.H'}, 'secondaryIdInfos': [{'id': 'IMSS-HGR1: 185-09-03-05/MPSS', 'type': 'OTHER', 'domain': 'Hospital General Regional #1 IMSS'}, {'id': 'ISSSTE 22-205/CEI 248/2009', 'type': 'OTHER', 'domain': 'Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Early Cancer placebo', 'description': 'The daily supplement of a vegetable colored water solution (drops) for 7 to 35 days in early breast cancer diagnosticated woman.\n\nPlacebo: vegetable colored water solution (drops). Evaluate the activity of placebo on tumor size, and molecular tumor response, as well as side effects attenuation', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Early Cancer Iodine', 'description': 'The daily supplement of an iodine solution (drops, 5 mg/day) for 7 to 35 days in early breast cancer diagnosticated woman', 'interventionNames': ['Drug: iodine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Advanced Cancer FEC/TE placebo', 'description': 'The daily supplement of an vegetable colored water solution (drops) within 4 to 6 cycles of chemotherapy with FEC/TE in advanced breast cancer diagnosticated woman.\n\nPlacebo: vegetable colored water solution (drops). Evaluate the adjuvancy of placebo in FEC/TE treatment on tumor size and molecular tumor response, as well as side effects attenuation.', 'interventionNames': ['Drug: FEC/TE Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Advanced Cancer FEC/TE + Iodine', 'description': 'The daily supplement of an iodine solution (drops, 5 mg/day) within 4 to 6 cycles of chemotherapy with FEC/TE in advanced breast cancer diagnosticated woman Drug: Iodine solution (5 mg/day). Evaluate the adjuvancy of I2 on FEC/TE treatment on tumor size and molecular tumor response, as well as side effects attenuation.\n\nOther Name: evaluating the adjuvancy of iodine supplement in FEC/TE treatment', 'interventionNames': ['Drug: FEC/TE iodine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'Selected patients with early breast cancer (stage II) non-pretreated received colored water solution (placebo) within the time before the hospital assigned them to her surgery (7 to 35 days).', 'armGroupLabels': ['Early Cancer placebo']}, {'name': 'iodine', 'type': 'DRUG', 'otherNames': ['experimental'], 'description': 'Selected patients with early breast cancer (stage II) non-pretreated received iodine solution (Experimental) within the time before the hospital assigned them to her surgery (7 to 35 days).', 'armGroupLabels': ['Early Cancer Iodine']}, {'name': 'FEC/TE Placebo', 'type': 'DRUG', 'description': 'The selected patients with advanced breast cancer (stage III) non-pretreated received colored water solution (placebo) within the time of oncology designed chemotherapy treatment FEC/TE (4 or 6 cycles/ every 21 days).', 'armGroupLabels': ['Advanced Cancer FEC/TE placebo']}, {'name': 'FEC/TE iodine', 'type': 'DRUG', 'description': 'The selected patients with advanced breast cancer (stage III) non-pretreated received iodine solution (experimental) within the time of oncology designed chemotherapy treatment (4 or 6 cycles/ every 21 days).', 'armGroupLabels': ['Advanced Cancer FEC/TE + Iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Querétaro City', 'state': 'Querétaro', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Guillermo Peralta Castillo, MD', 'role': 'CONTACT', 'email': 'drmemop@gmail.com', 'phone': '524424699698'}], 'facility': 'Hospital Médico TEC100', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}, {'zip': '76001', 'city': 'Querétaro City', 'state': 'Querétaro', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Carlos Avecilla, MD', 'role': 'CONTACT', 'email': 'drcavecilla@gmail.com', 'phone': '442 2154944'}, {'name': 'Jose Miguel Torres-Martel, MD', 'role': 'CONTACT', 'email': 'jmiguelmex@hotmail.com', 'phone': '524422381067'}], 'facility': 'Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}, {'zip': '76001', 'city': 'Querétaro City', 'state': 'Querétaro', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Joel Rojas, Md', 'role': 'CONTACT', 'email': 'joelro_onco@hotmail.com', 'phone': '52 442 216 26 62'}, {'name': 'Guillermo Peralta, MD', 'role': 'CONTACT', 'email': 'drmemop@gmail.com', 'phone': '524422381067'}], 'facility': 'Hospital General Regional #1 IMSS', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}], 'centralContacts': [{'name': 'Carmen Aceves, PhD', 'role': 'CONTACT', 'email': 'caracev@unam.mx', 'phone': '52 442 2381067'}], 'overallOfficials': [{'name': 'Carmen Aceves, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Nacional Autonoma de Mexico'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 12 months of study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primarily and secondary outcome measures will be made available', 'accessCriteria': 'Requestors will be required to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional Autonoma de Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital General Regional #1 IMSS, Queretaro México', 'class': 'UNKNOWN'}, {'name': 'Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico', 'class': 'UNKNOWN'}, {'name': 'Hospital Medico TEC100, Queretaro México', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigador Titular', 'investigatorFullName': 'Carmen Aceves', 'investigatorAffiliation': 'Universidad Nacional Autonoma de Mexico'}}}}