NCT05328258 Use of GnRHa During Chemotherapy for Fertility Protection
| NCT ID | NCT05328258 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kenny Rodriguez-Wallberg |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2023-03-31 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05328258 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 42 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05328258 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT05328258 currently recruiting?
Yes, NCT05328258 is actively recruiting participants. Contact the research team at kenny.rodriguez-wallberg@ki.se for enrollment information.
Where is the NCT05328258 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Gothenburg, Sweden, Gothenburg, Sweden, Lund, Sweden and 11 additional locations.
Who is sponsoring the NCT05328258 clinical trial?
NCT05328258 is sponsored by Kenny Rodriguez-Wallberg. The trial plans to enroll 500 participants.
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