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
• 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
• 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

Related Conditions & MeSH terms

• Amenorrhea
• Breast Cancer
• Menstrual Cycle

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

External Links

•   Memorial Sloan Kettering Cancer Center