Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT04536467
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-19
First Post:
2020-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Sponsor:
Beni-Suef University
Organization:
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 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)
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)
Study Oversight
Has Oversight DMC:
False
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?: