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

Launched by BENI-SUEF UNIVERSITY · Sep 1, 2020

Keywords

ClinConnect Summary

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...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Female lymphoma patients will be included in the study if they meet the following criteria:
• • 1. Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment
• • 2. Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)
• • 3. Female Age between 17- 40 years
• • 4. Written informed consent
• Exclusion criteria:
• The patients will be excluded from the study if they have the following criteria:
• • 1. Known hypersensitivity reaction to the investigational compounds or incorporated substances
• • 2. Primary ovarian dysfunction, previous history of amenorrhea \>3 months
• • 3. Age \> 40
• • 4. Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
• • 5. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)