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

• ClinicalTrials.gov Identifier: NCT04536467
• Recruitment Status: Enrolling by invitation
• First Posted: September 2, 2020
• Last Update Posted: December 8, 2021
• Sponsor: Beni-Suef University
• Collaborator: Cairo University
• Information provided by (Responsible Party): ALshaimaa Ibrahim Rabie, Beni-Suef University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Premature Ovarian Failure	Drug: Goserelin; Drug: Chemotherapy	Phase 2

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: 20-30 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

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: December 1, 2019
• Estimated Study Completion Date: June 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Goserelin arm; 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	Drug: Goserelin; chemotherapy+goserelin; Other Name: zoladex
control Arm; Standard chemotherapy	Drug: Chemotherapy; standard chemotherapy; Other Name: chemotherapy protocols

Outcome Measures

Primary Outcome Measures :

1. prevention premature ovarian failure [ Time Frame: 6 month from start of chemotherapy ]
   Evaluating ovarian function by FSH,E2 levels

Secondary Outcome Measures :

1. overall response in lymphoma patients [ Time Frame: 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.
2. ADVERSE EFFECTS [ Time Frame: 6 MONTH ]
   Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: woman age 17-40 years
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Egypt

Beni Suef university

Fayoum, Mesala, Egypt, 11858

Sponsors and Collaborators

Beni-Suef University

Cairo University

Investigators

• Study Director: Ahmed Abdullah Elberry Elberry, MD; Assistant Professor of Clinical Pharmacology, Beni-Suef University
• Study Director: Raghda Roshdy Sayed Hussein, MD; Lecturer of Clinical pharmacy, Beni-Suef University
• Study Director: ahmed hassan shaaban; Lecturer of Clinical Oncology, Beni-Suef University

More Information

• Responsible Party: ALshaimaa Ibrahim Rabie, assistant lecturer of clinical pharmacy department, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT04536467
• Other Study ID Numbers: FWA 00015574
• First Posted: September 2, 2020
• Last Update Posted: December 8, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Primary Ovarian Insufficiency; Menopause, Premature; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Goserelin; Antineoplastic Agents, Hormonal; Antineoplastic Agents