A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
|ClinicalTrials.gov Identifier: NCT00644683|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : June 6, 2014
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be affected by chemotherapy. There are a number of hormones which can be measured in the blood which are related to fertility and ovarian function. The levels of these hormones may change with chemotherapy, and may relate to the effect of chemotherapy on the ovaries.
In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with breast cancer and will be treated with chemotherapy. We will check blood levels of the hormones before, immediately after, and 1 year after treatment with chemotherapy. We will only be checking these blood tests for this study; the type of chemotherapy given will be up to the patient and her oncologist. We will also ask some questions about factors that can influence the levels of these hormones, such as number of children, age of menopause of other family members, and smoking history. The results from this study will be used to help us develop future studies looking at changes in ovarian function with chemotherapy, and the effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Observational Model:||Case Control|
|Official Title:||A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||September 2013|
- estimates of serum concentrations [ Time Frame: 1 year ]
To generate estimates of serum concentrations of inhibin A, inhibin B, and anti-Mullerian hormone in premenopausal breast cancer patients (25-50 years of age) before, immediately after, and 1 year following completion of chemotherapy.
Hypothesis: Serum concentrations of hormones involved in the hypothalamic-pituitary-ovarian axis (anti-Müllerian hormone, inhibin A, inhibin B, and follicle stimulating hormone) are detectable in the serum of all premenopausal women prior to chemotherapy
- serum concentrations of reproductive hormones [ Time Frame: 1 year ]
To determine serum concentrations of reproductive hormones (estradiol and its metabolites) before, immediately after, and 1 year following completion of chemotherapy using standard estradiol assays, and compare these results to those obtained using metabolomics.
Hypothesis: Serum concentrations of reproductive hormones (estradiol and its metabolites) will be detectable in all premenopausal women before chemotherapy, and will decrease immediately after chemotherapy in a considerable subset of patients. In addition, metabolomics will provide the same information about the presence or absence of estrogens, and will also provide additional data about other compounds present in the serum.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644683
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Norah L Henry, MD, PhD||University of Michigan|