Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
NCT Number: NCT06513962
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Interventions: OTHER: Best Practice|PROCEDURE: Biospecimen Collection|OTHER: Electronic Health Record Review|OTHER: Survey Administration|DRUG: Triptorelin Pamoate
Sponsor: Children's Oncology Group
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-12-18
Completion Date: 2029-10-30

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.

Primary Outcome Measures: Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years, Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time. Will help determine if a larger efficacy study can be successfully completed as a cross network trial in a reasonable funding period., Up to 4 years|Accrual rates of newly diagnosed AYA female cancer patients age < 40 years, Accrual rates of newly diagnosed AYA female cancer patients age \< 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period., Up to 4 years|Anti-mullerian hormone (AMH) levels, AMH values will be examined to confirm that the combined variability of AMH in both arms is consistent with our a priori assumptions., At 2 years post-chemotherapy
Secondary Outcome Measures: Longitudinal AMH along with other ovarian hormone levels, These measurements will help inform rates of missingness. Will be used to estimate the longitudinal trajectory of change in these hormones by triptorelin randomization status., Up to 2 years post-chemotherapy|Estrogen deprivation symptoms: Hot flashes, Estrogen deprivation symptoms include hot flashes. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of hot flashes., Up to 2 years post-chemotherapy|Estrogen deprivation symptoms: Headaches, Estrogen deprivation symptoms include headaches. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of headaches, Up to 2 years post-chemotherapy|Estrogen deprivation symptoms: Vaginal/vulvar symptoms, Estrogen deprivation symptoms include vaginal/vulvar symptoms. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of vaginal/vulvar symptoms. The PROMIS Sexual Function and Satisfaction version (v) 2.0 Brief Profile - Female (PROMIS SexFS) will be used to evaluate vaginal and vulvar discomfort, pain, and lubrication., Up to 2 years post-chemotherapy|Estrogen deprivation symptoms: Sexual function, Estrogen deprivation symptoms include sexual function. The Patient-Reported Outcomes version of the Common Terminology for Adverse Events (PRO-CTCAE) will be used to collect information on the frequency and interference of sexual function. The PROMIS Sexual Function and Satisfaction version (v) 2.0 Brief Profile - Female (PROMIS SexFS) will be used to evaluate sexual activity, desire, and satisfaction among all participants., Up to 2 years post-chemotherapy|Sexual Health, Sexual dysfunction will be assessed using PROMIS SexFS., Up to 2 years post-chemotherapy|Menstrual patterns, Menstrual patterns will be assessed using standard items and characterized according to the Staging of Reproductive Aging Workshop criteria., Up to 2 years post-chemotherapy|Global health-related quality of life: Anxiety, Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of anxiety. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale., Up to 2 years post-chemotherapy|Global health-related quality of life: Fatigue, Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of fatigue. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale., Up to 2 years post-chemotherapy|Global health-related quality of life: Depression, Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of depression. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale., Up to 2 years post-chemotherapy|Global health-related quality of life: Sleep disturbance, Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of sleep disturbance. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale., Up to 2 years post-chemotherapy|Global health-related quality of life: Participation in social activities, Global health-related quality of life will be assessed using the PROMIS 29 Profile v2.1, which includes assessment of participation in social activities. For adolescent participants, the PROMIS Pediatric Profile-25 v2.0 will be used to measure health domains, with the addition of the PROMIS Pediatric Sleep Disturbance 4a scale., Up to 2 years post-chemotherapy
Other Outcome Measures: Reproductive concerns, The reproductive concerns after cancer scale will be used for fertility potential and acceptance., Up to 2 years post-chemotherapy|Reproductive outcomes, Reproductive outcomes will be assessed using selected questions from the US Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey's (NHANES) Reproductive Health module., Up to 2 years post-chemotherapy