Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeUp to 39
SponsorChildren's Oncology Group
About this trial
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
< 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).
Disqualifiers
Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
Trial design
Design model
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive standard chemotherapy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Electronic Health Record Review
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Triptorelin Pamoate
DrugGiven IM
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Arm A (triptorelin)Experimental treatment 4 interventions
Group B: Arm B (usual care)Active comparator 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 2 years post-chemotherapy2
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.
Time frame
Up to 2 years post-chemotherapy3
Anti-mullerian hormone (AMH) levels
Feasibility of measuring AMH at two years post completion of alkylating agent-containing chemotherapy among randomized patients.
Time frame
At 2 years post-chemotherapySecondary outcomes
1
Longitudinal AMH along with other ovarian hormone levels
AMH will be collected at several timepoints from diagnosis to 2 years post cancer treatment completion. 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.
Time frame
Up to 2 years post-chemotherapy2
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.
Time frame
Up to 2 years post-chemotherapy3
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.
Time frame
Up to 2 years post-chemotherapy4
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.
Time frame
Up to 2 years post-chemotherapyOther outcomes
1
Reproductive concerns
The reproductive concerns after cancer scale will be used for fertility potential and acceptance.
Time frame
Up to 2 years post-chemotherapy2
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.
Time frame
Up to 2 years post-chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov