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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Drug: Goserelin; Drug: 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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Mesala
    • Fayoum, Mesala, Egypt, 11858
      • Beni Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: zoladex
Other: control Arm; Standard chemotherapy	Drug: Chemotherapy; standard chemotherapy; Other Names: chemotherapy protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevention premature ovarian failure	Evaluating ovarian function by FSH,E2 levels	6 month from start of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ADVERSE EFFECTS	Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)	6 MONTH

Collaborators and Investigators

• Sponsor: Beni-Suef 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Primary Ovarian Insufficiency; Menopause, Premature; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: FWA 00015574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No