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

NCT04536467 | Enrolling By Invitation Phase 2

• 1 other identifier: FWA 00015574
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

• prevention premature ovarian failure

  Evaluating ovarian function by FSH,E2 levels

  6 month from start of chemotherapy

Secondary Outcomes (2)

• overall response in lymphoma patients

  6 month

• ADVERSE EFFECTS

  6 MONTH

Study Arms (2)

Goserelin arm

OTHER

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

control Arm

OTHER

Standard chemotherapy

Drug: Chemotherapy

Interventions

Goserelin DRUG

chemotherapy+goserelin

Also known as: zoladex

Goserelin arm

Chemotherapy DRUG

standard chemotherapy

Also known as: chemotherapy protocols

control Arm

Eligibility Criteria

• Age: 17 Years - 40 Years
• Gender Eligibility Details: woman age 17-40 years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female lymphoma patients will be included in the study if they meet the following criteria:
• Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment
• Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)
• Female Age between 17- 40 years
• Written informed consent

You may not qualify if:

• The patients will be excluded from the study if they have the following criteria:
• Known hypersensitivity reaction to the investigational compounds or incorporated substances
• Primary ovarian dysfunction, previous history of amenorrhea \>3 months
• Age \> 40
• Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
• patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef university

Al Fayyum, Mesala, 11858, Egypt

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Goserelin; Drug Therapy; Antineoplastic Combined Chemotherapy Protocols

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics; Antineoplastic Protocols; Clinical Protocols; Drug Therapy, Combination

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacy department

Model Details: Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: March 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: November 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)