Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- prevention premature ovarian failure
研究概览
简要总结
To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Goserelin (Drug)
control Arm
Standard chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
prevention premature ovarian failure
时间窗: 6 month from start of chemotherapy
Evaluating ovarian function by FSH,E2 levels
次要结局
- overall response in lymphoma patients(6 month)
- ADVERSE EFFECTS(6 MONTH)
研究者
ALshaimaa Ibrahim Rabie
clinical pharmacy department
Beni-Suef University