Status:
RECRUITING
Use of GnRHa During Chemotherapy for Fertility Protection
Lead Sponsor:
Kenny Rodriguez-Wallberg
Conditions:
Breast Cancer Female
Acute Leukemia
Eligibility:
FEMALE
14-42 years
Phase:
PHASE3
Brief Summary
Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
- Confirmed menarche
- ECOG performance status 0-1
- Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders
Exclusion
- Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
- Previous or planned bilateral oophorectomy
- Pregnancy or breastfeeding at time of start of chemotherapy
- Other malignancy diagnosed within the last five years
- Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia
- Known osteoporosis
- Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias
- Known or suspected allergy against triptorelin
- Direct radiation of the gonads previous or planned (TBI allowed)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Key Trial Info
Start Date :
March 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2032
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05328258
Start Date
March 31 2023
End Date
January 31 2032
Last Update
October 27 2023
Active Locations (17)
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1
Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
Gothenburg, Sweden
2
Center for Pediatric Oncology, Akademiska Hospital
Gothenburg, Sweden
3
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
4
Department of Hematology, Skåne University Hospital
Lund, Sweden