Lymphoma Clinical Trial
Official title:
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 Model: Cohort, Time Perspective: Prospective
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