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

Hodgkin Lymphoma Clinical Trial

— OVARONKO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764230
• Other study ID #: Masaryk University
• Status: Completed
• Phase: N/A
• First received: December 30, 2012
• Last updated: January 7, 2013
• Start date: January 2004
• Est. completion date: January 2008

Study information

• Verified date: January 2013
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Grant Agency of the Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	Brno University Hospital and Masaryk University School of Medicine	Brno

Sponsors (2)

Lead Sponsor	Collaborator
Masaryk University	Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature ovarian failure after chemotherapy	Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.	6 months after the end of chemotherapy	No
Primary	Premature ovarian failure after chemotherapy	Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.	12 months after the end of chemotherapy	No
Secondary	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	6 months after the end of chemotherapy	No
Secondary	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	12 month after chemotherapy	No