Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

Withdrawn

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

• Registration Number: NCT00402935
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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 Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-23
• Study Completion: 2007-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States