Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

Lymphoma Clinical Trial

Official title: Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

Status Withdrawn

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.

Clinical Trial 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

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

• NCT number: NCT00402935
• Study type: Observational
• Source: Case Comprehensive Cancer Center
• Status: Withdrawn
• Phase: N/A
• Start date: February 2004
• Completion date: May 2007