- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00402935
Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
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.
Study Overview
Status
Conditions
- Lymphoma
- Unspecified Childhood Solid Tumor, Protocol Specific
- Leukemia
- Unspecified Adult Solid Tumor, Protocol Specific
- Long-term Effects Secondary to Cancer Therapy in Children
- Long-term Effects Secondary to Cancer Therapy in Adults
- Sexuality and Reproductive Issues
- Sexual Dysfunction and Infertility
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.
Study Type
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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.
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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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marjorie Greenfield, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- unspecified adult solid tumor, protocol specific
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- secondary acute myeloid leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- untreated childhood acute lymphoblastic leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- long-term effects secondary to cancer therapy in adults
- long-term effects secondary to cancer therapy in children
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- recurrent adult acute lymphoblastic leukemia
- recurrent childhood acute lymphoblastic leukemia
- adult acute lymphoblastic leukemia in remission
- stage IV childhood Hodgkin lymphoma
- recurrent childhood acute myeloid leukemia
- stage III childhood Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- untreated adult acute lymphoblastic leukemia
- sexual dysfunction and infertility
- sexuality and reproductive issues
- untreated childhood acute myeloid leukemia and other myeloid malignancies
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWRU3803
- P30CA043703 (U.S. NIH Grant/Contract)
- CASE-CWRU-3803 (Other Identifier: Case Comprehensive Cancer Center)
- CASE-01-04-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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