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Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Active, not recruiting
Conditions
Breast Cancer
Menstrual Cycle
Amenorrhea
Interventions
Other: Questionnaire
Registration Number
NCT00589654
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
810
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
1Questionnaire-
Primary Outcome Measures
NameTimeMethod
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.Conclusion of the study
Secondary Outcome Measures
NameTimeMethod
Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variablesConclusion of study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

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