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

Not Applicable

Completed

• Conditions: Hodgkin Lymphoma; Hodgkin Disease
• Interventions: Drug: triptorelin

• Registration Number: NCT01764230
• Lead Sponsor: Masaryk University

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-07
• Study Completion: 2008-01
• Study First Submitted: 2012-12-30
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-07
• Last Update Submitted: 2013-01-07
• Study First Posted: 2013-01-09
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
case group	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.

Primary Outcome Measures

Name	Time	Method
Premature ovarian failure after chemotherapy	12 months after the end of chemotherapy	Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.

Secondary Outcome Measures

Name	Time	Method
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen	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

Trial Locations

Locations (1)

Brno University Hospital and Masaryk University School of Medicine; 🇨🇿 Brno, Czech Republic