Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
Children's Oncology Group
Summary
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
Description
PRIMARY OBJECTIVES: I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age \< 40 years (exclusive of breast cancer). II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients. SECONDARY OBJECTIVES: I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment…
Eligibility
- Age range
- Up to 39 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * \< 40 years of age 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. (Current menstrual status is not part of the inclusion criteria.) * Newly diagnosed with first cancer, exclusive of breast cancer. * Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma). * Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, pro…
Interventions
- OtherBest Practice
Receive standard chemotherapy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- OtherSurvey Administration
Ancillary studies
- DrugTriptorelin Pamoate
Given IM
Locations (193)
- Children's Hospital of AlabamaBirmingham, Alabama
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- USA Health Strada Patient Care CenterMobile, Alabama
- Phoenix Childrens HospitalPhoenix, Arizona
- Mercy Hospital Fort SmithFort Smith, Arkansas
- Arkansas Children's HospitalLittle Rock, Arkansas