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Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589654
First Posted: January 10, 2008
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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:


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.

  Eligibility

Information from the National Library of Medicine

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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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00589654     History of Changes
Other Study ID Numbers: 97-127
DAMD17966292
First Submitted: December 26, 2007
First Posted: January 10, 2008
Last Update Posted: January 6, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes