Clinical trial NCT02677311: GnRHA Therapy and Ovarian Preservation in Pediatric Cancer Patient
Official title: Gonadotropin Releasing Hormone Agonist (GnRHa) Therapy and Ovarian Preservation in Pediatric and Adolescent Subject Receiving Chemoradiation Therap
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Chemoradiation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 2
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective case control study. Participants will be enrolled as case subjects or control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The chemotherapeutic regimens will be determined per standard of care. Participants will receive GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the interventions. The duration of the study will be approximately 12 months.The study time includes the time necessary for completion of most cancer treatments in this population, which approximates 8-12 months, and time to allow complete excretion of the Lupron from the systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O) axis. The results of the study will be used to guide a larger study evaluating the efficacy of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young subjects receiving chemoradiation.

Detailed description: This study will not utilize a survey or questionnaire. Data will be collected via chart review and direct subject and/or guardian interviews.

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.

Eligibility criteria: Inclusion Criteria:

* Receiving chemoradiation therapy
* 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:

* Under 8 years of age and older than 19 years of age
* Male
* Unable to provide consent or assent

Primary outcomes:
measure: Ovarian Reserve - AMH
timeFrame: 6 months post completion of chemotherapy
measure: Ovarian Reserve - AMH
timeFrame: 12 months post completion of chemotherapy
measure: Ovarian Reserve - Menstrual function
timeFrame: 12 months post completion of chemotherapy
measure: Ovarian Reserve - FSH
timeFrame: 6 months post completion of chemotherapy
measure: Ovarian Reserve - FSH
timeFrame: 12 months post completion of chemotherapy
measure: Ovarian Reserve - Menstrual function
timeFrame: 6 months post completion of chemotherapy
Secondary outcomes:
measure: Ovarian Reserve - Agreement of AMH and AFC
timeFrame: Pre-GnRHa therapy, 6 months post and 12 post completion of chemotherapy
Other outcomes:
Locations:
Study officials:
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