Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity

May 14, 2021 updated by: Xiangyun Zong

Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200233
        • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal women 18 to 49 years of age are eligible for enrollment
  • Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
  • Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
  • Human chorionic gonadotropin negative by urine test before entering the group.
  • Informed consent, understanding and compliance with the requirements of the study.
  • No significant chronic disease and any organ dysfunction.

Exclusion Criteria:

  • Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
  • Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
  • Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
  • Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
  • Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
  • Allergic to active or inactive excipients of GnRHa is an exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GnRHa group
Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.
Drug: GnRHa
3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
Other Names:
  • goserelin
No Intervention: None GnRHa group
Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Premature Ovarian Insufficiency
Time Frame: 1 years
The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH<0.5ng/mL in this study.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: 5 years
Overall Survival & Tumor Free Survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangyun Zong

Collaborators

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: XIANGYUN ZONG, MD, PhD, Shanghai Jiao Tong University affiliated 6th Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JTU-6H-20150731001

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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