Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402935
Status:
WITHDRAWN
Last Update Posted:
2012-03-20
First Post:
2006-11-21
Brief Title:
Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer
Detailed Description:
OBJECTIVES
Determine the incidence and timing of ovarian dysfunctiondamage 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
Determine the incidence and timing of ovarian dysfunctiondamage 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-01-04-15 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CASE-CWRU-3803 | OTHER | None | None |