Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients (OVARONKO)

January 7, 2013 updated by: Martin Huser, Masaryk University
Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent implications and among the most common is infertility as a result of irreversible gonadal damage. This project sets the primary target to verify the protective effect GnRH analogues administration to protect ovarian tissue during three different regimens of chemotherapy in patients with Hodgkin disease (HD) in reproductive age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the first two years of the project duration the curative anti-tumorous combined treatment in fertile patients with Hodgkin disease diagnosis will be carried out. Patients are to be divided into three groups according to the clinical stage of the disease and treated with the three types of the chemotherapeutic regimens comparable with toxicity. Patients will receive GnRH analogues during the chemotherapy for the gonadal protection by the mechanism of foliculogenesis inhibition in pre-pubertal stage. At the end of successful treatment according to stated criteria the ovarian function of every patient will be repeatedly evaluated in relation with toxicity of chemotherapy used. These ovarian function results will be compared with control group of patients without gonadal protection, which reproductive functions will be evaluated according the same method.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

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

  • Czech Republic
      • Brno, Czech Republic, 62500
        • Brno University Hospital and Masaryk University School of Medicine

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • diagnosis of Hodgkin lymphoma
  • FSH and LH levels in peripheral blood below 15 IU/l
  • fertile age from 18 to 35 years
  • female
  • presence of both ovaries

Exclusion Criteria:

  • ovarian tumours or cysts over 40 mm in diameter

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
no intervention
Experimental: case group
Throughout the course of chemotherapy, patients were administered triptorelin (Diphereline SR 3 mg, Ibsen) in the form of i.m. injections, always once a month and simultaneously with the chemotherapy.
Drug: triptorelin
Throughout the course of chemotherapy, patients were administered triptorelin (Diphereline SR 3 mg, Ibsen) in the form of i.m. injections, always once a month and simultaneously with the chemotherapy.
Other Names:
  • triptorelin (Diphereline SR 3 mg, Ibsen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature ovarian failure after chemotherapy
Time Frame: 6 months after the end of chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
6 months after the end of chemotherapy
Premature ovarian failure after chemotherapy
Time Frame: 12 months after the end of chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
12 months after the end of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
Time Frame: 6 months after the end of chemotherapy

A - ABVD 4x Adriamycin, bleomycin, vinblastin and dacarbazin

B Combination of ABVD and BEACOPP regimens 4x Adriamycin, bleomycin, vinblastin and dacarbazinþbleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone

C BEACOPP regimen 8x - Bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone
6 months after the end of chemotherapy
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
Time Frame: 12 month after chemotherapy

A - ABVD 4x Adriamycin, bleomycin, vinblastin and dacarbazin

B Combination of ABVD and BEACOPP regimens 4x Adriamycin, bleomycin, vinblastin and dacarbazinþbleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone

C BEACOPP regimen 8x - Bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone
12 month after chemotherapy

Collaborators and Investigators

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

Sponsor

Masaryk University

Collaborators

Ministry of Health, Czech Republic

Investigators

  • Principal Investigator: Martin Huser, MD, PhD, Masaryk University

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

January 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 30, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Masaryk University

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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