NCT04536467

Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 17 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy

Detailed description

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)

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
DRUG	Goserelin	chemotherapy+goserelin
DRUG	Chemotherapy	standard chemotherapy

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-12-01
• Completion: 2024-11-01
• First posted: 2020-09-02
• Last updated: 2024-03-19

Locations

1 site across 1 country: Egypt