Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
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|ClinicalTrials.gov Identifier: NCT00402935|
Recruitment Status : Withdrawn (slow accrual)
First Posted : November 23, 2006
Last Update Posted : March 20, 2012
RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment.
PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.
|Condition or disease||Intervention/treatment|
|Leukemia Long-term Effects Secondary to Cancer Therapy in Adults Long-term Effects Secondary to Cancer Therapy in Children Lymphoma Sexual Dysfunction and Infertility Sexuality and Reproductive Issues Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Other: laboratory biomarker analysis Procedure: fertility assessment and management Procedure: management of therapy complications Procedure: ultrasound imaging|
- Determine the incidence and timing of ovarian dysfunction/damage in younger premenopausal women undergoing cytotoxic chemotherapy for cancer.
- Determine the feasibility of a prospective, randomized study to assess if gonadotropin analogues can protect the ovary from the cytotoxic effects of chemotherapy.
- Determine the number of patients required for adequate power to test the hypothesis.
OUTLINE: This is a pilot, prospective study.
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function|
|Study Start Date :||February 2004|
|Actual Study Completion Date :||May 2007|
Other: laboratory biomarker analysis
- Incidence of ovarian damage after cytotoxic chemotherapy as determined by changes in ovarian volume, antral follicle count, and follicle-stimulating hormone, estradiol, and inhibin B levels [ Time Frame: Ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points. ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402935
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Marjorie Greenfield, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|