Actively Recruiting
Use of GnRHa During Chemotherapy for Fertility Protection
Led by Kenny Rodriguez-Wallberg · Updated on 2023-10-27
500
Participants Needed
17
Research Sites
461 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Use of GnRHa During Chemotherapy for Fertility Protection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed with breast cancer, acute leukemias, lymphomas (Hodgkin or non-Hodgkin), or sarcomas (osteosarcoma, soft tissue sarcoma, or Ewing sarcoma) confirmed by histology and planned for disease-specific chemotherapy
- Confirmed menarche (have started menstruating)
- ECOG performance status of 0 or 1
- Adequate bone marrow, kidney, liver, and heart function
- No uncontrolled medical or psychiatric disorders
You will not qualify if you...
- Premature ovarian failure at the time of randomization based on clinical or biochemical data
- Previous or planned removal of both ovaries (bilateral oophorectomy)
- Pregnant or breastfeeding at the start of chemotherapy
- Diagnosis of another cancer within the last five years
- Uncontrolled high blood pressure or uncontrolled heart, liver, kidney, or other medical or psychiatric disorders, including anorexia
- Known osteoporosis
- Low platelet count with bleeding risk or refractory thrombocytopenia in acute leukemia patients
- Known or suspected allergy to triptorelin
- Previous or planned direct radiation to the gonads (total body irradiation allowed)
- Mental inability, reluctance, or language difficulties that hinder understanding of study participation
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
Gothenburg, Sweden
Not Yet Recruiting
2
Center for Pediatric Oncology, Akademiska Hospital
Gothenburg, Sweden
Not Yet Recruiting
3
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
Not Yet Recruiting
4
Department of Hematology, Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
5
Department of Oncology, Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
6
Department of Pediatric Oncology, Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
7
Department of Oncology, Örebro University Hospital
Örebro, Sweden
Active, Not Recruiting
8
Karolinska Univeristy Hospital, Breast Centre
Stockholm, Sweden, 17176
Actively Recruiting
9
Department of Hematology and coagulation, Sahlgrenska University Hospital
Stockholm, Sweden
Not Yet Recruiting
10
Department of Hematology, Capio ST. Göran Hospital
Stockholm, Sweden
Not Yet Recruiting
11
Department of Internal Medicine, Södersjukhuset
Stockholm, Sweden
Not Yet Recruiting
12
Department of Oncology, Capio ST. Göran Hospital
Stockholm, Sweden
Not Yet Recruiting
13
Department of Oncology, Södersjukhuset
Stockholm, Sweden
Not Yet Recruiting
14
Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet
Stockholm, Sweden
Actively Recruiting
15
Karolinska University Hospital, Hematology
Stockholm, Sweden
Actively Recruiting
16
Karolinska University Hospital, High Specialised Pediatric Medicine
Stockholm, Sweden
Actively Recruiting
17
Department of Oncology, Norrlands University Hospital
Umeå, Sweden
Not Yet Recruiting
Research Team
K
Kenny Rodriguez Wallberg, MD, PhD
CONTACT
H
Hanna Nilsson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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