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

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04536467
• Other study ID #: FWA 00015574
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: November 1, 2024
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Drug:
• Goserelin
chemotherapy+goserelin
• Chemotherapy
standard chemotherapy

Locations

Country	Name	City	State
Egypt	Beni Suef university	Fayoum	Mesala

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention premature ovarian failure	Evaluating ovarian function by FSH,E2 levels	6 month from start of chemotherapy
Secondary	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
Secondary	ADVERSE EFFECTS	Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)	6 MONTH