Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
This trial is active, not recruiting.
|Conditions||amenorrhea, menstrual cycle, breast cancer|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||December 1997|
|End date||December 2017|
|Trial size||810 participants|
|Trial identifier||NCT00589654, 97-127, DAMD17966292|
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.
The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance.
time frame: Conclusion of the study
Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables
time frame: Conclusion of study
Female participants from 18 years up to 45 years old.
Inclusion Criteria: - Non-institutional (community dwelling) woman of any race - Between 18-45 years at the first screening visit - Have regular menstrual cycles - Diagnosed with invasive breast cancer stage I, II, III within the previous eight months - Have physician agreement for patient participation Exclusion Criteria: - No menstrual bleeding cycles - Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance - Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer) - Stage IV breast malignancy - Residency outside United States - No telephone
|Official title||Menstrual Cycle Maintenance and Quality of Life: A Prospective Study|
|Principal investigator||Kimberly Van Zee, MD|
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