Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients (OVARONKO)
Primary Purpose
Hodgkin Lymphoma, Hodgkin Disease
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
triptorelin
Sponsored by
About this trial
This is an interventional supportive care trial for Hodgkin Lymphoma focused on measuring Hodgkin lymphoma, Hodgkin disease
Eligibility 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
Sites / Locations
- Brno University Hospital and Masaryk University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
case group
control group
Arm Description
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.
no intervention
Outcomes
Primary Outcome Measures
Premature ovarian failure after chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Premature ovarian failure after chemotherapy
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
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
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
Full Information
NCT ID
NCT01764230
First Posted
December 30, 2012
Last Updated
January 7, 2013
Sponsor
Masaryk University
Collaborators
Ministry of Health, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT01764230
Brief Title
Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
Acronym
OVARONKO
Official Title
Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Masaryk University
Collaborators
Ministry of Health, Czech Republic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Hodgkin Disease
Keywords
Hodgkin lymphoma, Hodgkin disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
case group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
triptorelin (Diphereline SR 3 mg, Ibsen)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Premature ovarian failure after chemotherapy
Description
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Time Frame
6 months after the end of chemotherapy
Title
Premature ovarian failure after chemotherapy
Description
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Time Frame
12 months after the end of chemotherapy
Secondary Outcome Measure Information:
Title
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
Description
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
Time Frame
6 months after the end of chemotherapy
Title
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
Description
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
Time Frame
12 month after chemotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Huser, MD, PhD
Organizational Affiliation
Masaryk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brno University Hospital and Masaryk University School of Medicine
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
18258763
Citation
Huser M, Crha I, Ventruba P, Hudecek R, Zakova J, Smardova L, Kral Z, Jarkovsky J. Prevention of ovarian function damage by a GnRH analogue during chemotherapy in Hodgkin lymphoma patients. Hum Reprod. 2008 Apr;23(4):863-8. doi: 10.1093/humrep/den005. Epub 2008 Feb 7.
Results Reference
result
Learn more about this trial
Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
We'll reach out to this number within 24 hrs