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

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

Detailed Description
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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)

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

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Drug: Goserelin
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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 Age > 40 Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Goserelin arm<br>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 | Drug: Goserelin<br>* chemotherapy+goserelin<br>* Other names: zoladex;|
| Other: control Arm<br>Standard chemotherapy | Drug: Chemotherapy<br>* standard chemotherapy<br>* Other names: chemotherapy protocols;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention premature ovarian failure | Evaluating ovarian function by FSH,E2 levels | 6 month from start of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response in lymphoma patients | 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. | 6 month | 
| ADVERSE EFFECTS | Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches) | 6 MONTH |