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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Amenorrhea Breast Cancer Breast Diseases Breast Neoplasms Menstrual Cycle Menstruation Disturbances Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

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 outcomes

Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables

Time frame: Conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 1997
Primary completion: 2026
Study completion: 2026
First posted: Jan 10, 2008
Registry last updated: Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed