Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

NCT00589654 | Active Not Recruiting

• 2 other identifiers: 97-127DAMD17966292
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 1

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.

Conditions

Amenorrhea; Menstrual Cycle; Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Conclusion of study

Study Arms (1)

1

Other: Questionnaire

Interventions

Questionnaire OTHER

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

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Amenorrhea; Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tracy-Ann Moo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: December 1, 1997
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)