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Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00402935
First received: November 21, 2006
Last updated: March 16, 2012
Last verified: March 2012
History of Changes

November 21, 2006
March 16, 2012
February 2004
Not Provided
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. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00402935 on ClinicalTrials.gov Archive Site
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Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

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.

OBJECTIVES:

  • 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
Non-Probability Sample

premenopausal women undergoing chemotherapy for cancer
  • 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
    Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
  • Procedure: fertility assessment and management
    Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
  • Procedure: management of therapy complications
    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.
  • Procedure: ultrasound imaging
    Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2007
Not Provided

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer, including, but not limited to, any of the following:

    • Acute lymphocytic leukemia
    • Acute myeloid leukemia
    • Hodgkin's lymphoma
  • Must have primary disease with significant chance for long-term survival after therapy

  • Scheduled to receive chemotherapeutic agents known to be associated with ovarian failure, including any of the following:

    • Cyclophosphamide
    • Mechlorethamine hydrochloride
    • Busulfan
    • Procarbazine hydrochloride
    • Chlorambucil
    • Melphalan
    • Ifosfamide
    • Cisplatin
    • Carboplatin
  • Postmenarchal and premenopausal

PATIENT CHARACTERISTICS:

  • Female
  • Weight ≤ 250 pounds
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • No prior or concurrent total-body irradiation or radiotherapy to the pelvis
  • Concurrent bone marrow transplantation allowed
  • Concurrent oral contraception and/or gonadotropin releasing-hormone analogue allowed
Female
14 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00402935
CWRU3803, P30CA043703, CASE-CWRU-3803, CASE-01-04-15
Yes
Marjorie Greenfield, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Marjorie Greenfield, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP