Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00402935
First received: November 21, 2006
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
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 |
Other: laboratory biomarker analysis Procedure: fertility assessment and management Procedure: management of therapy complications Procedure: ultrasound imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Hodgkin Disease
Infertility
Leukemia
Lymphoma
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
| Enrollment: | 0 |
| Study Start Date: | February 2004 |
| Study Completion Date: | May 2007 |
Intervention Details:
Detailed Description:
-
Other: laboratory biomarker analysis
Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
Procedure: fertility assessment and management
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
Procedure: management of therapy complications
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.
Procedure: ultrasound imaging
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
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| Ages Eligible for Study: | 14 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
premenopausal women undergoing chemotherapy for cancer
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402935
Locations
| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Marjorie Greenfield, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marjorie Greenfield, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00402935 History of Changes |
| Other Study ID Numbers: | CWRU3803, P30CA043703, CASE-CWRU-3803, CASE-01-04-15 |
| Study First Received: | November 21, 2006 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Infertility Leukemia Lymphoma Sexual Dysfunctions, Psychological Neoplasms Genital Diseases, Male Genital Diseases, Female |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013