Clinical trial NCT00402935: Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
Official title: Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: 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
Keywords: 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)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: premenopausal women undergoing chemotherapy for cancer

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.

Eligibility 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

Primary outcomes:
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
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Marjorie Greenfield, MD
role: PRINCIPAL_INVESTIGATOR
References: