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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
Martin Huser, Masaryk University
ClinicalTrials.gov Identifier:
NCT01764230
First received: December 30, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Hodgkin Lymphoma
Hodgkin Disease
Drug: triptorelin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by Masaryk University:

Primary Outcome Measures:
  • Premature ovarian failure after chemotherapy [ Time Frame: 6 months after the end of chemotherapy ] [ Designated as safety issue: No ]
    Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.

  • Premature ovarian failure after chemotherapy [ Time Frame: 12 months after the end of chemotherapy ] [ Designated as safety issue: No ]
    Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.


Secondary Outcome Measures:
  • Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen [ Time Frame: 6 months after the end of chemotherapy ] [ Designated as safety issue: No ]

    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


  • Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen [ Time Frame: 12 month after chemotherapy ] [ Designated as safety issue: No ]

    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



Enrollment: 72
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: triptorelin (Diphereline SR 3 mg, Ibsen)
No Intervention: control group
no intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01764230

Locations
Czech Republic
Brno University Hospital and Masaryk University School of Medicine
Brno, Czech Republic, 62500
Sponsors and Collaborators
Masaryk University
Ministry of Health, Czech Republic
Investigators
Principal Investigator: Martin Huser, MD, PhD Masaryk University
  More Information

Publications:
Responsible Party: Martin Huser, MD, PhD., Masaryk University
ClinicalTrials.gov Identifier: NCT01764230     History of Changes
Other Study ID Numbers: Masaryk University
Study First Received: December 30, 2012
Last Updated: January 7, 2013
Health Authority: Czech Republic: Grant Agency of the Ministry of Health

Keywords provided by Masaryk University:
Hodgkin lymphoma
Hodgkin disease

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014