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Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00589654
First received: December 26, 2007
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Amenorrhea
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables [ Time Frame: Conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 810
Study Start Date: December 1997
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589654

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00589654     History of Changes
Other Study ID Numbers: 97-127, DAMD17966292
Study First Received: December 26, 2007
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
amenorrhea
menstrual cycle
Breast cancer
questionnaire
97-127

Additional relevant MeSH terms:
Amenorrhea
Breast Neoplasms
Menstruation Disturbances
Pathologic Processes
 Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 17, 2012