Hodgkin LymphomaOVARONKONCT01764230
Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
A study testing triptorelin in people with Hodgkin Lymphoma and Hodgkin Disease, run by Masaryk University at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hodgkin Lymphoma, Hodgkin Disease
- What is being tested?
- triptorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2004to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- ovarian tumours or cysts over 40 mm in diameter
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Brno University Hospital and Masaryk University School of Medicine
Brno, 62500
About this study
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.
Read the 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.
- Conditions
- Hodgkin Lymphoma, Hodgkin Disease
- Being tested
- triptorelin
- Keywords
- Hodgkin lymphoma, Hodgkin disease
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triptorelinDrug
Also called triptorelin (Diphereline SR 3 mg, Ibsen)
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.
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | 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. Receives: Drug: triptorelin |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature ovarian failure after chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Measured: 6 months after the end of chemotherapy
Premature ovarian failure after chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Measured: 12 months after the end of chemotherapy
Secondary outcomes (2)
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
Measured: 6 months after the end of chemotherapy
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
Measured: 12 month after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2004
- Primary completionJul 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Responsible party
- Principal investigator, Martin Huser, Masaryk University
- Investigators
- Martin Huser, MD, PhD, Principal investigator, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764230
- Sponsor's protocol ID
- Masaryk University
- Acronym
- OVARONKO
- Status last verified
- Jan 2013
- First submitted
- 30 Dec 2012
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18258763
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
- ClinicalTrials.gov ID
- NCT01764230
- Acronym / sponsor ID
- OVARONKO / Masaryk University
- Conditions
- Hodgkin Lymphoma, Hodgkin Disease
- Keywords
- Hodgkin lymphoma, Hodgkin disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- Jan 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Drug: triptorelinThroughout 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. |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- ovarian tumours or cysts over 40 mm in diameter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triptorelinAlso: triptorelin (Diphereline SR 3 mg, Ibsen)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 | case group |
Primary outcome
Premature ovarian failure after chemotherapy
Time frame: 6 months after the end of chemotherapy
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
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
2 secondary outcomes
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
Time frame: 6 months after the end of chemotherapy
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
Time frame: 12 month after chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
- Results publication: PubMed 18258763Huser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Huser, MD, PhD principal investigator
Masaryk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triptorelin in people with Hodgkin Lymphoma and Hodgkin Disease, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature ovarian failure after chemotherapy (time frame: 6 months after the end of chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2013.