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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 42
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
NOT_YET_RECRUITING
Gothenburg
Center for Pediatric Oncology, Akademiska Hospital
NOT_YET_RECRUITING
Gothenburg
Department of Oncology, Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Department of Hematology, Skåne University Hospital
NOT_YET_RECRUITING
Lund
Department of Oncology, Skåne University Hospital
NOT_YET_RECRUITING
Lund
Department of Pediatric Oncology, Skåne University Hospital
NOT_YET_RECRUITING
Lund
Department of Oncology, Örebro University Hospital
ACTIVE_NOT_RECRUITING
Örebro
Department of Hematology and coagulation, Sahlgrenska University Hospital
NOT_YET_RECRUITING
Stockholm
Department of Hematology, Capio ST. Göran Hospital
NOT_YET_RECRUITING
Stockholm
Department of Internal Medicine, Södersjukhuset
NOT_YET_RECRUITING
Stockholm
Department of Oncology, Capio ST. Göran Hospital
NOT_YET_RECRUITING
Stockholm
Department of Oncology, Södersjukhuset
NOT_YET_RECRUITING
Stockholm
Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet
RECRUITING
Stockholm
Karolinska Univeristy Hospital, Breast Centre
RECRUITING
Stockholm
Karolinska University Hospital, Hematology
RECRUITING
Stockholm
Karolinska University Hospital, High Specialised Pediatric Medicine
RECRUITING
Stockholm
Department of Oncology, Norrlands University Hospital
NOT_YET_RECRUITING
Umeå
Contact Information
Primary
Kenny Rodriguez Wallberg, MD, PhD
kenny.rodriguez-wallberg@ki.se
+46 858580000
Backup
Hanna Nilsson, PhD
hanna.nilsson@ki.se
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2032-01-31
Participants
Target number of participants: 500
Treatments
Experimental: Arm A: Triptorelin
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_comparator: Arm B: Placebo
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.
Sponsors
Leads: Kenny Rodriguez-Wallberg

This content was sourced from clinicaltrials.gov

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