Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Breast Cancer; Amenorrhea; Menstrual Cycle

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT00589654

DAMD17966292

97-127

Details and patient eligibility

About

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.

Enrollment: 810 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

810 participants in 1 patient group

1

Treatment:

Other: Questionnaire