Use of GnRHa During Chemotherapy for Fertility Protection
Recruiting · NCT05328258 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 preserve the fertility of young female cancer subjects. Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment. The patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection. Patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
17 locations listed.
- Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth - Gothenburg, Sweden
- Center for Pediatric Oncology, Akademiska Hospital - Gothenburg, Sweden
- Department of Oncology, Sahlgrenska University Hospital - Gothenburg, Sweden
- Department of Hematology, Skåne University Hospital - Lund, Sweden
- Department of Oncology, Skåne University Hospital - Lund, Sweden
- Department of Pediatric Oncology, Skåne University Hospital - Lund, Sweden
- Karolinska Univeristy Hospital, Breast Centre - Stockholm, Sweden
- Department of Hematology and coagulation, Sahlgrenska University Hospital - Stockholm, Sweden
- Department of Hematology, Capio ST. Göran Hospital - Stockholm, Sweden
- Department of Internal Medicine, Södersjukhuset - Stockholm, Sweden
- Department of Oncology, Capio ST. Göran Hospital - Stockholm, Sweden
- Department of Oncology, Södersjukhuset - Stockholm, Sweden
- Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet - Stockholm, Sweden
- Karolinska University Hospital, Hematology - Stockholm, Sweden
- Karolinska University Hospital, High Specialised Pediatric Medicine - Stockholm, Sweden
- Department of Oncology, Norrlands University Hospital - Umeå, Sweden
- Department of Oncology, Örebro University Hospital - Örebro, Sweden