Clinical trial NCT04536467: Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Official title: Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Premature Ovarian Failure
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy
Primary purpose: PREVENTION

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)

Eligibility criteria: 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)

Primary outcomes:
measure: prevention premature ovarian failure
timeFrame: 6 month from start of chemotherapy
Secondary outcomes:
measure: overall response in lymphoma patients
timeFrame: 6 month
measure: ADVERSE EFFECTS
timeFrame: 6 MONTH
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Beni Suef university
state: Mesala
Study officials:
affiliation: Assistant Professor of Clinical Pharmacology, Beni-Suef University
name: Ahmed Abdullah Elberry Elberry, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of Clinical pharmacy, Beni-Suef University
name: Raghda Roshdy Sayed Hussein, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of Clinical Oncology, Beni-Suef University
name: ahmed hassan shaaban
role: STUDY_DIRECTOR
References: