Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536467
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-19
First Post:
2020-08-27
Brief Title:
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 36 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
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 36 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None