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Use of GnRHa During Chemotherapy for Fertility Protection

RecruitingPhase 3Ages 14 Years - 42 YearsFemaleKenny Rodriguez-Wallberg
NCT05328258 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 injectio

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📋 Eligibility rules (as published)
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
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What it tests

  • Triptorelin Embonate
  • Sodium Chloride solution 0.9%
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Where

17 sites
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
Department of Oncology, Örebro University Hospital
Örebro, Sweden
Karolinska Univeristy Hospital, Breast Centre
Stockholm, Sweden

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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