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

Beni-Suef University

Status and phase: Invitation-only; Phase 2

Conditions: Premature Ovarian Failure

Treatments: Drug: Goserelin; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04536467

FWA 00015574

Details and patient eligibility

About

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

Full 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)

Enrollment: 80 estimated patients

Sex: Female

Ages: 17 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Goserelin arm

Other group

Description:

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

Treatment:

Drug: Goserelin

control Arm

Other group

Description:

Standard chemotherapy

Treatment:

Drug: Chemotherapy