Using GnRHa to protect fertility during chemotherapy for young women
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
This study is testing if a hormone treatment can help young women keep their ability to have children while they undergo chemotherapy for cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 14 Years to 42 Years |
| Sex | Female |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 17 sites (Gothenburg and 16 other locations) |
| Trial ID | NCT05328258 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Gonadotropin-Releasing Hormone agonist (GnRHa) to preserve fertility in young women undergoing chemotherapy for various cancers, including breast cancer and acute leukemias. Approximately 500 women will be recruited and randomly assigned to receive either the experimental drug triptorelin or a placebo during their chemotherapy treatment. The study employs a double-blind design, ensuring that neither the participants nor the investigators know which treatment is being administered. Participants will be monitored for up to five years post-treatment to assess the long-term effects on fertility.
Who should consider this trial
Good fit: Ideal candidates include young women diagnosed with breast cancer, acute leukemias, lymphomas, or sarcomas who are about to begin chemotherapy.
Not a fit: Patients with premature ovarian failure, those who have undergone oophorectomy, or those with other uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance fertility preservation options for young women diagnosed with cancer.
How similar studies have performed: Previous studies have shown promising results in fertility preservation using GnRHa during chemotherapy, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg and 16 other locations
- Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth — Gothenburg, Sweden (Not_yet_recruiting)
- Center for Pediatric Oncology, Akademiska Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Department of Oncology, Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Department of Hematology, Skåne University Hospital — Lund, Sweden (Not_yet_recruiting)
- Department of Oncology, Skåne University Hospital — Lund, Sweden (Not_yet_recruiting)
- Department of Pediatric Oncology, Skåne University Hospital — Lund, Sweden (Not_yet_recruiting)
- Department of Oncology, Örebro University Hospital — Örebro, Sweden (Active_not_recruiting)
- Karolinska Univeristy Hospital, Breast Centre — Stockholm, Sweden (Recruiting)
- Department of Hematology and coagulation, Sahlgrenska University Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Department of Hematology, Capio ST. Göran Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Department of Internal Medicine, Södersjukhuset — Stockholm, Sweden (Not_yet_recruiting)
- Department of Oncology, Capio ST. Göran Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Department of Oncology, Södersjukhuset — Stockholm, Sweden (Not_yet_recruiting)
- Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet — Stockholm, Sweden (Recruiting)
- Karolinska University Hospital, Hematology — Stockholm, Sweden (Recruiting)
- Karolinska University Hospital, High Specialised Pediatric Medicine — Stockholm, Sweden (Recruiting)
- Department of Oncology, Norrlands University Hospital — Umeå, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Kenny Rodriguez Wallberg, MD, PhD
- Email: kenny.rodriguez-wallberg@ki.se
- Phone: +46 858580000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.