Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

This study is ongoing, but not recruiting participants.

First Received: December 26, 2007 Last Updated: January 9, 2008 History of Changes

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00589654

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menstruation

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	810
Study Start Date:	December 1997
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (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 ( Kimberly Van Zee MD )
Study ID Numbers:	97-127, DAMD17966292
Study First Received:	December 26, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00589654 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

amenorrhea
menstrual cycle
Breast cancer
questionnaire
97-127

Study placed in the following topic categories:

Skin Diseases
Menstruation Disturbances
Amenorrhea

Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Pathologic Processes
Skin Diseases

Menstruation Disturbances
Amenorrhea
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009