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: February 5, 2014
Last verified: February 2014

December 26, 2007
February 5, 2014
December 1997
December 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589654 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Stage 1-3 breast cancer patients 18-45 years of age will be identified. Those with normal menstrual cycles will be eligible.

  • Amenorrhea
  • Menstrual Cycle
  • Breast Cancer
Other: Questionnaire
Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.
1
Intervention: Other: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
810
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589654
97-127, DAMD17966292
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Kimberly Van Zee, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP