Hodgkin Disease, Hodgkin Lymphoma
Conditions
Keywords
Hodgkin lymphoma, Hodgkin disease
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.
Interventions
DRUGtriptorelin
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.
Sponsors
Ministry of Health, Czech Republic
Masaryk University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premature ovarian failure after chemotherapy | 6 months after the end of chemotherapy | Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen | 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 |
Countries
Czechia
Outcome results
None listed