Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

Lymphoma Clinical Trial

Official title:

Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00402935
• Other study ID #: CWRU3803
• Secondary ID: P30CA043703CASE-
• Status: Withdrawn
• Phase: N/A
• First received: November 21, 2006
• Last updated: March 16, 2012
• Start date: February 2004
• Est. completion date: May 2007

Study information

• Verified date: March 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Leukemia
• Long-term Effects Secondary to Cancer Therapy in Adults
• Long-term Effects Secondary to Cancer Therapy in Children
• Lymphoma
• Neoplasm Metastasis
• Sexual Dysfunction and Infertility
• Sexuality and Reproductive Issues
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

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.
• 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.
• ultrasound imaging
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database