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NCT00589654 Clinical Trial

Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Breast Cancer Clinical Trial

Official title:
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00589654
Other study ID # 97-127
Secondary ID DAMD17966292
Status Active, not recruiting
Phase
First received
Last updated
Start date December 1997
Est. completion date December 2024

Study information
Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 810
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables Conclusion of study
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