Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT05840068
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IGF Level in Breast Cancer Patients Treated With Metformin
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': 'D008687', 'term': 'Metformin'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IGF-1 levels', 'timeFrame': '6 months.', 'description': 'IGF-1 levels were measured before and after treatment.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 Year', 'description': 'The measurement values of IGF were divided into two groups, high and low, based on the cut off value. After a year of observation, researchers in both groups compared their progression-free survival (PFS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin', 'Breast cancer', 'IGF'], 'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '26293146', 'type': 'BACKGROUND', 'citation': 'Ko KP, Ma SH, Yang JJ, Hwang Y, Ahn C, Cho YM, Noh DY, Park BJ, Han W, Park SK. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial. Breast Cancer Res Treat. 2015 Sep;153(2):361-70. doi: 10.1007/s10549-015-3519-8. Epub 2015 Aug 21.'}, {'pmid': '36233373', 'type': 'BACKGROUND', 'citation': 'Essa NM, Salem HF, Elgendy MO, Gabr A, Omran MM, Hassan NA, Tashkandi HM, Harakeh S, Boshra MS. Efficacy of Metformin as Adjuvant Therapy in Metastatic Breast Cancer Treatment. J Clin Med. 2022 Sep 20;11(19):5505. doi: 10.3390/jcm11195505.'}, {'pmid': '19029956', 'type': 'RESULT', 'citation': 'Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.', 'detailedDescription': 'One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with MBC\n* patients older than 18\n* nondiabetic patients\n* patients who received only chemotherapy\n\nExclusion Criteria:\n\n* patients with non-metastatic breast cancer\n* patients receiving hormonal therapy or radiotherapy\n* patients with diabetes\n* history of cardiac diseases\n* hypersensitivity, or allergy to metformin.'}, 'identificationModule': {'nctId': 'NCT05840068', 'briefTitle': 'IGF Level in Breast Cancer Patients Treated With Metformin', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'IGF level in breast cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin and Chemotherapy', 'description': 'Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)', 'interventionNames': ['Drug: MetFORMIN 500 Mg Oral Tablet', 'Drug: Chemotherapy']}, {'type': 'OTHER', 'label': 'Chemotherapy alone', 'description': 'Chemotherapy is administered alone to Group B (n=50).', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'MetFORMIN 500 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Glucophage 500 oral tablet and Chemotherapy'], 'description': 'MetFORMIN 500 Mg Oral Tablet', 'armGroupLabels': ['Metformin and Chemotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['Chemotherapy alone'], 'description': 'The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).', 'armGroupLabels': ['Chemotherapy alone', 'Metformin and Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62514', 'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Marian S. Boshra', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Marian S. Boshra', 'investigatorAffiliation': 'Beni-Suef University'}}}}