Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00402935

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

38.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

Study Start Date :

Feb 1, 2004

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

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 [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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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