Premature Ovarian Failure Clinical Trial
Official title:
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy
Design: Study 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 Evaluating ovarian function by: at the start of treatment and after 3 cycles chemotherapy treatment and at end of 6 cycles chemotherapy through: - FSH level (follicle-stimulating hormone (FSH)) - Estradiol level - AMH level follow up time time frame 1 year follow up after chemotherapy Secondary Outcome Measures: - 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. - Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches) ;
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