A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00644683
First received: January 17, 2008
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • estimates of serum concentrations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • serum concentrations of reproductive hormones [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.

    2



Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 28
Study Start Date: September 2007
Study Completion Date: September 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and 50.

Criteria

Inclusion Criteria:

  • Subjects must be women with a histologically confirmed invasive adenocarcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease.
  • Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients may receive concurrent trastuzumab as indicated. If a patient has not yet undergone final surgical resection, it must be highly likely (but is not required to be definite) that the patient will be treated with adjuvant chemotherapy.
  • Patients must have:

    • Reached their 25th birthday and not yet reached their 51st birthday at the time of study enrollment, AND
    • Had menses within 3 months prior to starting chemotherapy
  • Patients must not have received prior cytotoxic chemotherapy for any oncologic, rheumatologic, or dermatologic condition.
  • Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must not have had prior hysterectomy
  • ECOG performance status 0 - 2
  • Pregnant or nursing women may not participate. Women of reproductive potential must agree to use an effective non-hormonal contraceptive method, such as condoms, tubal ligation, non-hormonal intrauterine device, partner sterilization, and abstinence during chemotherapy.
  • All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644683

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Lynn Henry
Investigators
Principal Investigator: Norah L Henry, MD, PhD University of Michigan
  More Information

Publications:
Responsible Party: Lynn Henry, Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00644683     History of Changes
Other Study ID Numbers: UMCC 2007.081, HUM 00014246
Study First Received: January 17, 2008
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
premenopausal women with breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 14, 2014