GnRHA Therapy and Ovarian Preservation in Pediatric Cancer Patient

Cancer Clinical Trial

Official title:

Gonadotropin Releasing Hormone Agonist (GnRHa) Therapy and Ovarian Preservation in Pediatric and Adolescent Subject Receiving Chemoradiation Therap

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02677311
• Other study ID #: 15-0596-F2L
• Status: Terminated
• Phase: N/A
• First received: December 20, 2015
• Last updated: October 24, 2017
• Start date: September 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemoradiation

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian Reserve - AMH	Assess AMH change from baseline to 6 months.	6 months post completion of chemotherapy
Primary	Ovarian Reserve - AMH	Assess AMH change from baseline to 12 months.	12 months post completion of chemotherapy
Primary	Ovarian Reserve - Menstrual function	Assess menstrual function change from baseline to 12 year.	12 months post completion of chemotherapy
Primary	Ovarian Reserve - FSH	Assess FSH change from baseline to 6 months.	6 months post completion of chemotherapy
Primary	Ovarian Reserve - FSH	Assess FSH change from baseline to 12 months.	12 months post completion of chemotherapy
Primary	Ovarian Reserve - Menstrual function	Assess menstrual function change from baseline to 6 months.	6 months post completion of chemotherapy
Secondary	Ovarian Reserve - Agreement of AMH and AFC	To assess the agreement of AMH (< or equal to 0.5 vs. > 0.5) and AFC (<16 follicles vs 16+ follicles) as indicators of ovarian reserve after chemoradiation and GnRHa therapy	Pre-GnRHa therapy, 6 months post and 12 post completion of chemotherapy