Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT04536467
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-19
First Post:
2020-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000971', 'term': 'Antineoplastic Combined Chemotherapy Protocols'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D024221', 'term': 'Antineoplastic Protocols'}, {'id': 'D002985', 'term': 'Clinical Protocols'}, {'id': 'D004359', 'term': 'Drug Therapy, Combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-17', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevention premature ovarian failure', 'timeFrame': '6 month from start of chemotherapy', 'description': 'Evaluating ovarian function by FSH,E2 levels'}], 'secondaryOutcomes': [{'measure': 'overall response in lymphoma patients', 'timeFrame': '6 month', 'description': 'Overall response rate determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations , ( RECIL 2017) The overall response evaluation criteria in lymphoma, criteria categorized patients stable disease,progressive disease ,minor response,partial response,complete response at end of 6 months.'}, {'measure': 'ADVERSE EFFECTS', 'timeFrame': '6 MONTH', 'description': 'Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Ovarian Failure']}, 'descriptionModule': {'briefSummary': 'To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy', 'detailedDescription': 'Design:\n\nStudy will be prospective interventional simple randomized control parallel open label Arms and Interventions Arm 1: Goserelin plus standard chemotherapy Goserelin will be given as a 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months (26) Arm 2 (control Arm): Standard chemotherapy Patients will take only standard chemotherapy for 3 months Setting: oncology department Beni Suef university hospital Sample size: 80 patients (based on the results from the literature and to ensure a power of 80% and a type I error probability of 5%. we calculate Effect size Primary Outcome Measures\n\nEvaluating ovarian function by: at the start of treatment and after 3 cycles chemotherapy treatment and at end of 6 cycles chemotherapy through:\n\n* FSH level (follicle-stimulating hormone (FSH))\n* Estradiol level\n* AMH level follow up time time frame 1 year follow up after chemotherapy\n\nSecondary Outcome Measures:\n\n* Overall All Response determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations according RECIL 2017 criteria.\n* Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '17 Years', 'genderBased': True, 'genderDescription': 'woman age 17-40 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale lymphoma patients will be included in the study if they meet the following criteria:\n\n1. Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment\n2. Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)\n3. Female Age between 17- 40 years\n4. Written informed consent\n\nExclusion criteria:\n\nThe patients will be excluded from the study if they have the following criteria:\n\n1. Known hypersensitivity reaction to the investigational compounds or incorporated substances\n2. Primary ovarian dysfunction, previous history of amenorrhea \\>3 months\n3. Age \\> 40\n4. Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection\n5. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)'}, 'identificationModule': {'nctId': 'NCT04536467', 'briefTitle': 'Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients', 'orgStudyIdInfo': {'id': 'FWA 00015574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Goserelin arm', 'description': '3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months', 'interventionNames': ['Drug: Goserelin']}, {'type': 'OTHER', 'label': 'control Arm', 'description': 'Standard chemotherapy', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Goserelin', 'type': 'DRUG', 'otherNames': ['zoladex'], 'description': 'chemotherapy+goserelin', 'armGroupLabels': ['Goserelin arm']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['chemotherapy protocols'], 'description': 'standard chemotherapy', 'armGroupLabels': ['control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11858', 'city': 'Al Fayyum', 'state': 'Mesala', 'country': 'Egypt', 'facility': 'Beni Suef university', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'overallOfficials': [{'name': 'Ahmed Abdullah Elberry Elberry, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Clinical Pharmacology, Beni-Suef University'}, {'name': 'Raghda Roshdy Sayed Hussein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Clinical pharmacy, Beni-Suef University'}, {'name': 'ahmed hassan shaaban', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Clinical Oncology, Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical pharmacy department', 'investigatorFullName': 'ALshaimaa Ibrahim Rabie', 'investigatorAffiliation': 'Beni-Suef University'}}}}