Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure
Information source: Erasme University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Function Restoration After Chemotherapy for Lymphoma
Intervention: GnRH agonist (triptorelin)+ Norethisterone acetate (Drug); Norethisterone acetate (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Erasme University Hospital Official(s) and/or principal investigator(s): Yvon Englert, MD, PhD, Study Director, Affiliation: Erasme Hospital
Summary
Chemotherapy drugs like alkylating agents are frequently used in various combined regimens
to treat neoplastic and benign diseases. These drugs are definitely associated with
premature ovarian failure (POF), resulting in an important decrease of the long-term quality
of life and an increase of morbidity. A recent study showed that the patients treated by
alkylating agents had a 4. 52 fold higher risk to lose their ovarian function compared with
those who were treated by other agents. The rate of POF after treatment ranged from 40 to
80%, according to the age of the patients and the total doses administered.
Young women who experience POF have to face with the prospects of infertility and to
consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage
by administering of protective therapy during chemotherapy represents an attractive option
for these patients.
The aim of this study is to evaluate the protective effect on the ovarian function of the
gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating
agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data
in human are, however, highly controversial.
Clinical Details
Official title: A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Premature ovarian failure rate
Secondary outcome: Impact of the flare-up effect of TriptorelinOvarian function during the treatment Number of Participants with Adverse Events as a Measure of Safety and Tolerability Add back therapy effect
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women between 18 and 45 years old with lymphoma.
- Menarche >2year
- Subject treated by chemotherapy-induced ovarian failure including alkylant agents
(except less than 8 ABVD)
- Presence of both ovaries (ovarian biopsy or hemiovariectomy for cryopreservation
before treatment is accepted).
- Ability to give written informed consent
Exclusion Criteria:
- Hormonal-sensible malignancy
- Chemotherapy or radiotherapy before the inclusion in the study
- Pelvic irradiation including the ovaries or TBI
- Pregnancy
- Patient weight above 110 kg
- Anamnesis of thrombo-embolic processes
- Severe hepatic or renal insufficiency
- Systolic blood pressure >15mmHg or diastolic blood pressure > 90mmHg
- Contraindication of IM injection
- Relevant ovarian abnormalities (Functional follicular cyst are tolerated)
- Anamnesis of premature ovarian failure or irregular cycle (repeated amenorrhoea >2
months)
- Dubin-Johnson and Rotor Syndrome
Locations and Contacts
Algemeen Ziekenhuis Stuivenberg, Antwerpen 2060, Belgium
AZ St Jan, Brugges 8000, Belgium
AZ-VUB, Brussels 1090, Belgium
Bordet, Brussels 1000, Belgium
Erasme Hospital, Brussels 1070, Belgium
St Luc University, Brussels 1200, Belgium
CHRU Lille, Lille 59037, Belgium
CHU Dijon, Dijon 21034, France
CHU Nancy, Nancy 54511, France
Henry-Mondor Hospital, Paris-Creteil 94010, France
CHU St Antoine, Paris 75571, France
Hôpital Hotel Dieu, Paris 75004, France
St Louis Hospital, Paris 75475, France
Centre Henri Beckerel, Rouen 76038, France
Instituto Europeo di oncologia, Milano 1-20141, Italy
Additional Information
Starting date: July 2002
Last updated: July 30, 2010
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