Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Anticipated Enrollment :
810 participants
Observational Model:
Time Perspective:
Official Title:
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Study Start Date :
Dec 1, 1997
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables [Conclusion of study]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center Identifier:
Other Study ID Numbers:
  • 97-127
  • DAMD17966292
First Posted:
Jan 10, 2008
Last Update Posted:
Jan 4, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2022