GnRHA Therapy and Ovarian Preservation in Pediatric Cancer Patient
NCT ID: NCT02677311
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2015-09-30
2017-05-31
Brief Summary
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Detailed Description
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Electronic medical records will be accessed only by approved clinical and research personnel to retrieve clinical and laboratory data.
At the initial visit, the following will be performed and collected on all subjects: Body Mass Index; age at thelarche; age at menarche; Tanner staging for breast and pubic hair; oncologic diagnosis; date of oncologic diagnosis; chemoradiation therapy treatment regimen; date of initiation of chemoradiation therapy; pre-treatment ovarian function blood tests; date GnRHa therapy initiated; a pelvic ultrasound will be performed to assess ovarian volumes and antral follicle count.
The subject will receive GnRHa 11.25 mg every 2 months until completion of chemotherapy, which is consistent with current clinical care at the University of Kentucky Medical Center (UKMC).
Study blood tests to evaluate ovarian function and pelvic ultrasound will be performed at three time points: immediately prior to initiation of GnRHa therapy and 6 and 12 months after chemoradiation therapy is completed.
The subject/guardian will be contacted by the study team at regular intervals to assess her progress and plan timing of study visits.
At subsequent visits, the investigator will record the date chemoradiation therapy treatment ended; date and reason GnRHa therapy discontinued; presence of breakthrough bleeding (BTB); timing of BTB in relation to most recent GnRHa injection. In order to document bleeding patterns, subjects will be asked to fill out the pictorial assessment of bleeding chart every month that they are in the study.
Six months after completion of chemoradiation therapy, the investigator will assess post-treatment ovarian function blood test levels and performed a pelvic U/S to assess ovarian volumes and antral follicle count. Investigator will as assess the resumption of spontaneous menses, parity, date of subject demise, if applicable.
Twelve months after completion of chemotherapy, we will assess post-treatment ovarian function blood test levels; and performed a pelvic U/S to assess ovarian volumes and antral follicle count. Investigator will as assess the resumption of spontaneous menses, parity, date of subject demise, if applicable.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Cases
Participants who will receive gonadotoxic chemoradiation therapies to include the alkylating agents, heavy metals and plant alkaloids as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.
Blood draw
Blood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Pelvic Ultrasound
Pelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Controls
Participants who will receive chemoradiation therapies presumed to be low risk for gonadotoxicity as determined by the literature and the patient's oncolologist as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.
Blood draw
Blood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Pelvic Ultrasound
Pelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Interventions
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Blood draw
Blood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Pelvic Ultrasound
Pelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Eligibility Criteria
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Inclusion Criteria
* Documented ovarian function
* Require menstrual suppression with GnRHa during chemoradiation therapy
* Patients at the University of Kentucky, Norton Healthcare or Cincinnati Children's Hospital Medical Center
Exclusion Criteria
* Male
* Unable to provide consent or assent
8 Years
19 Years
FEMALE
No
Sponsors
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University of Kentucky
OTHER
Responsible Party
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Other Identifiers
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15-0596-F2L
Identifier Type: -
Identifier Source: org_study_id