Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Overview
- Phase
- Phase 2
- Intervention
- Goserelin
- Conditions
- Premature Ovarian Failure
- Sponsor
- Beni-Suef University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- prevention premature ovarian failure
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief 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)
Investigators
ALshaimaa Ibrahim Rabie
clinical pharmacy department
Beni-Suef University
Eligibility Criteria
Inclusion Criteria
- •Female lymphoma patients will be included in the study if they meet the following criteria:
- •Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment
- •Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)
- •Female Age between 17- 40 years
- •Written informed consent
- •Exclusion criteria:
- •The patients will be excluded from the study if they have the following criteria:
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances
- •Primary ovarian dysfunction, previous history of amenorrhea \>3 months
- •Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
Exclusion Criteria
- Not provided
Arms & Interventions
Goserelin arm
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
Intervention: Goserelin
control Arm
Standard chemotherapy
Intervention: Chemotherapy
Outcomes
Primary Outcomes
prevention premature ovarian failure
Time Frame: 6 month from start of chemotherapy
Evaluating ovarian function by FSH,E2 levels
Secondary Outcomes
- overall response in lymphoma patients(6 month)
- ADVERSE EFFECTS(6 MONTH)