Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00589654

Enrollment

810

Registered

2008-01-10

Start date

1997-12-01

Completion date

2026-12-01

Last updated

2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea, Breast Cancer, Menstrual Cycle

Keywords

amenorrhea, menstrual cycle, Breast cancer, questionnaire, 97-127

Brief summary

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.

Interventions

OTHERQuestionnaire

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	Conclusion of the study

Secondary

Measure	Time frame
Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables	Conclusion of study

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTracy-Ann Moo, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026