Use of GnRHa During Chemotherapy for Fertility Protection (ProFertil)
Breast Cancer Female, Acute Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring Fertility protection of young women receiving chemotherapy
Eligibility Criteria
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
Sites / Locations
- Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
- Center for Pediatric Oncology, Akademiska Hospital
- Department of Oncology, Sahlgrenska University Hospital
- Department of Hematology, Skåne University Hospital
- Department of Oncology, Skåne University Hospital
- Department of Pediatric Oncology, Skåne University Hospital
- Karolinska Univeristy Hospital, Breast Centre
- Department of Hematology and coagulation, Sahlgrenska University Hospital
- Department of Hematology, Capio ST. Göran Hospital
- Department of Internal Medicine, Södersjukhuset
- Department of Oncology, Capio ST. Göran Hospital
- Department of Oncology, Södersjukhuset
- Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet
- Karolinska University Hospital, Hematology
- Karolinska University Hospital, High Specialised Pediatric Medicine
- Department of Oncology, Norrlands University Hospital
- Department of Oncology, Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm A: Triptorelin
Arm B: Placebo
Triptorelin given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment. The dose is ether 11.25 mg triptorelin given for subjects having at least 3 months gonadotoxic treatment, OR 3.75 mg for subjects during one-month of gonadotoxic treatment
Placebo, 0.9% sodium chloride, given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment. The dose will be provided both as one injection compensating for 3 months' effect and one injection compensating for 1 month' effect to maintain the study blind.