Tests a hormone drug to protect fertility during cancer chemotherapy in young women
Tests triptorelin, or placebo, to help protect fertility in young women with cancer.
Plain-language title generated from the registry record
Registry title: Use of GnRHa During Chemotherapy for Fertility Protection
Key facts
- Where
- Goteborg, Gothenburg, Huddinge, Lund, Malmo, Orebro, Solna, Stockholm, Umea, and Uppsala, SwedenSee the 11 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 42 years old?
Source: NCT05328258, who can take part
Where in Sweden
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SwedenNot yet recruiting
- Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra GoetalandsregionenGothenburg, SwedenNot yet recruiting
- Karolinska University HospitalHuddinge, SwedenNot yet recruiting
- Region Skane Skanes UniversitetssjukhusLund, SwedenNot yet recruiting
- Region Skane Skanes UniversitetssjukhusMalmo, SwedenNot yet recruiting
- Region Oerebro LaenOrebro, SwedenNot yet recruiting
- Karolinska University HospitalSolna, SwedenNot yet recruiting
- Capio S:t Goerans Sjukhus ABStockholm, SwedenNot yet recruiting
- Soedersjukhuset ABStockholm, SwedenNot yet recruiting
- Region VaesterbottenUmea, SwedenNot yet recruiting
- Uppsala University HospitalUppsala, SwedenNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kenny Rodriguez-Wallberg
- Trial code
- NCT05328258EU 2024-518977-32-00
- Record updated
- 27 October 2023
- Original description
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.Read full original descriptionShow less
A Phase 3 Randomised Double-Blinded Placebo-Controlled Study of Use of GnRHa During Chemotherapy for Fertility Protection of Young Women and Teenagers With Cancer
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.
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: Previous or planned bilateral oophorectomy; Pregnancy or breastfeeding at time of start of chemotherapy; Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia; Direct radiation of the gonads previous or planned (TBI allowed); Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data; Other malignancy diagnosed within the last five years; Known or suspected allergy against triptorelin; Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias; Known osteoporosis; Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation.