Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

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

Treatments: Other: laboratory biomarker analysis; Procedure: management of therapy complications; Procedure: ultrasound imaging; Procedure: fertility assessment and management

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00402935

CASE-01-04-15

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CWRU-3803 (Other Identifier)

CWRU3803

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 14 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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