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

Phase 2

• Conditions: Premature Ovarian Failure
• Interventions: Drug: Chemotherapy; Drug: Goserelin

• Registration Number: NCT04536467
• Lead Sponsor: Beni-Suef University

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 Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-02
• Primary Completion: 2020-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 80

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control Arm	Chemotherapy	Standard chemotherapy
Goserelin arm	Goserelin	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

Primary Outcome Measures

Name	Time	Method
prevention premature ovarian failure	6 month from start of chemotherapy	Evaluating ovarian function by FSH,E2 levels

Secondary Outcome Measures

Name	Time	Method
ADVERSE EFFECTS	6 MONTH	Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)
overall response in lymphoma patients	6 month	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.

Trial Locations

Locations (1)

Beni Suef university; 🇪🇬 Fayoum, Mesala, Egypt