LeukemiaNCT00402935
Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
An observational study of Leukemia and Long-term Effects Secondary to Cancer Therapy in Adults, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 35 years, women only
- Conditions the study is for
- Leukemia, Long-term Effects Secondary to Cancer Therapy in Adults, Long-term Effects Secondary to Cancer Therapy in Children
- What is being tested?
- laboratory biomarker analysis, fertility assessment and management and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: premenopausal women undergoing chemotherapy for cancer
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the 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.
- 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
- Being tested
- laboratory biomarker analysis, fertility assessment and management, management of therapy complications, ultrasound imaging
- 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
- Medical subject headings
- Leukemia, Lymphoma, Sexual Dysfunction, Physiological, Infertility, Sexuality, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
fertility assessment and managementProcedure or surgery
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
management of therapy complicationsProcedure or surgery
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.
ultrasound imagingProcedure or surgery
Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startFeb 2004
- Study completionMay 2007
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Marjorie Greenfield, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402935
- Sponsor's protocol ID
- CWRU3803
- Other IDs
- P30CA043703, CASE-CWRU-3803, CASE-01-04-15
- Status last verified
- Mar 2012
- First submitted
- 21 Nov 2006
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function
- ClinicalTrials.gov ID
- NCT00402935
- Acronym / sponsor ID
- CWRU3803
- 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
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- Study completion
- May 2007 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- premenopausal women undergoing chemotherapy for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisPatients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. | Other | – |
| fertility assessment and managementPatients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles. | Procedure or surgery | – |
| management of therapy complicationsPatients 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 or surgery | – |
| ultrasound imagingPatients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie Greenfield, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Long-term Effects Secondary to Cancer Therapy in Adults, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.