Overview

This trial is active, not recruiting.

Conditions amenorrhea, menstrual cycle, breast cancer
Treatment questionnaire
Sponsor Memorial Sloan Kettering Cancer Center
Start date December 1997
End date December 2016
Trial size 810 participants
Trial identifier NCT00589654, 97-127, DAMD17966292

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
questionnaire
Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables
time frame: Conclusion of study

Eligibility Criteria

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

Additional Information

Official title Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Principal investigator Kimberly Van Zee, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.