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

Sponsor
Beni-Suef University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04536467
Collaborator
Cairo University (Other)
80
Enrollment
1
Location
2
Arms
51
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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
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
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapyArm 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 :
Mar 1, 2019
Actual Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. prevention premature ovarian failure [6 month from start of chemotherapy]

      Evaluating ovarian function by FSH,E2 levels

    Secondary Outcome Measures

    1. 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.

    2. ADVERSE EFFECTS [6 MONTH]

      Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Sep 2, 2020
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Goserelin

    Study Results

    No Results Posted as of Dec 8, 2021