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Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function


N/A
14 Years
35 Years
Not Enrolling
Female
Leukemia, Long-term Effects Secondary to Cancer Therapy in Adults, Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma, Sexual Dysfunction and Infertility, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Marjorie Greenfield, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU3803

NCT ID:

NCT00402935

Start Date:

February 2004

Completion Date:

May 2007

Related Keywords:

  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Lymphoma
  • Sexual Dysfunction and Infertility
  • Sexuality and Reproductive Issues
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • long-term effects secondary to cancer therapy in adults
  • long-term effects secondary to cancer therapy in children
  • sexual dysfunction and infertility
  • sexuality and reproductive issues
  • adult acute lymphoblastic leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated childhood acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • secondary acute myeloid leukemia
  • stage I adult Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • childhood acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Infertility
  • Leukemia
  • Lymphoma
  • Sexual Dysfunctions, Psychological
  • Neoplasms

Name

Location
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065