Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer

Reproductive health outcomes, including the possibility of infertility from cancer treatment, are a major source of distress for adolescent and young adult (AYA) patients from diagnosis through survivorship. The overarching objective of this study is to investigate the impact of the Gonadotropin Releasing Hormone agonist (GnRHa) triptorelin, as a randomized intervention, on the ovarian reserve of newly diagnosed AYA cancer patients (exclusive of breast cancer) treated with alkylating agent chemotherapy. This trial is supported by the NCI Community Oncology Research Program (NCORP), led by the Children’s Oncology Group (COG), and is open as a cross network trial to NCORPs and non-NCORP sites. To demonstrate feasibility, in this initial phase, 60 AYA female subjects < 40 years of age will be enrolled. Randomization will be stratified by age (< 20, 20–29, 30–< 40). Once feasibility can be demonstrated, the ultimate goal will be to enroll up to 250 participants in order to assess the effect of triptorelin on the difference in anti&#x2;Mullerian hormone (AMH), a biomarker of ovarian reserve, at two years from the completion of alkylating agent therapy between the randomized arms. The overall study will impact future clinical practice by providing a strong evidence base for the utility (or disutility) of GnRHa on ovarian reserve among newly diagnosed AYA cancer patients. In addition to measurements of ovarian reserve, the study will collect relevant patient- reported outcomes, including symptoms and quality of life over time, as differences in these domains may be as important to participants as measurements of ovarian reserve

Are you Eligible? (Inclusion Criteria)

• Age: Patients must be < 40 years at the time of enrollment -Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. -Diagnosis: Newly diagnosed with first cancer, exclusive of breast -Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard