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Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: December 26, 2007
Last updated: January 4, 2017
Last verified: January 2017
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.

Condition Intervention
Menstrual Cycle
Breast Cancer
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables [ Time Frame: Conclusion of study ]

Estimated Enrollment: 810
Study Start Date: December 1997
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Questionnaire
Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage 1-3 breast cancer patients 18-45 years of age will be identified. Those with normal menstrual cycles will be eligible.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00589654

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Kimberly Van Zee, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00589654     History of Changes
Other Study ID Numbers: 97-127
Study First Received: December 26, 2007
Last Updated: January 4, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
menstrual cycle
Breast cancer

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes processed this record on May 25, 2017