Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer

A Prospective, Longitudinal Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer

The purpose of this study is to see how many patients develop hair, skin and nail changes due to cancer treatments. The investigators would like to study the clinical factors, genetic markers, and impact on patients' health-related quality of life to learn more about who is at greater risk. We trust that the study will improve our understanding of how cancer patients feel about their skin, hair, and nail conditions. This information will help us determine the burden on breast cancer patients and survivors. It will also help us learn how to prevent these conditions and it may improve the way we treat them and counsel patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Questionnaires; Other: Clinical Assessments; Other: Saliva sample

• Study Type: Observational
• Enrollment (Estimated): 546

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

Description

Inclusion Criteria:

• Women newly diagnosed with non-metastatic breast cancer (stage 0-III, any receptor type) at the time of starting chemotherapy (dd-AC-T, CMF, Newer Combination Regimens) or endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane)
• Women ≥ 18 years at the time of enrollment into the study
• Able to communicate in English and participate in the informed consent process
• Able to comply with the follow-up visits, assessments, answering questionnaires

Exclusion Criteria:

• Metastatic breast cancer
• Follow-up care/visits not scheduled at MSKCC
• Any current alopecia especially due to an active scalp and/or hair disorder (e.g. alopecia areata), or a pre-existing condition with sequelae (e.g. scarring alopecia)
• Currently active or uncontrolled medical condition [e.g. thyroid disorder, auto-immune connective tissue disease (e.g. SLE), BMT complications (GVHD)] or medication intake (e.g. HRT), affecting scalp hair
• Prior systemic treatment for any malignancy
• Active secondary cancer requiring cytotoxic chemotherapy
• Planned (or a history of) radiation therapy to the head
• Vulnerable populations [e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
• Men

Volunteer Inclusion Criteria:

• Post menopausal women, with menopausal status defined as (per self report):
• Bilateral salpingo-oophorectomy independent of age
• If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
• Or premenopausal women with premenopausal status defined as <53 years of age with no cessation of menses
• Able to communicate in English and participate in the informed consent process
• Able to comply with the baseline assessments and answering questionnaires
• Women >/= 18 years at the time of enrollment into the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients having CYTOTOXIC CHEMOTHERAPY; Participants will undergo study related assessments and the appropriate HRQoL questionnaires will be administered. Baseline and follow-up clinical assessments will be performed, preferably when the patient presents to the clinic for (clinically indicated) standard-of-care visits. Initially, these visits will be coinciding with the appropriate chemotherapy dosing cycles (as applicable to select study cohorts), and subsequently they will be performed during the standard-of-care follow-up visits.	Behavioral: Questionnaires; Other: Clinical Assessments; Other: Saliva sample; (only once, preferably at baseline)
Patients having ENDOCRINE THERAPY; Participants will undergo study related assessments and Medical and Personal History Questionnaire data collection forms and the appropriate HRQoL questionnaires, will be administered. Baseline and follow-up clinical assessments will be performed, preferably when the patient presents to the clinic for standard-of-care visits. Initially, these visits will be coinciding with the appropriate therapy and subsequently they will be performed during the standard-of-care follow-up visits.	Behavioral: Questionnaires; Other: Clinical Assessments; Other: Saliva sample; (only once, preferably at baseline)
COMPARATOR (menopausal women); Menopausal women will include unrelated visitors accompanying breast cancer patients (e.g. friends) attending the breast medicine or dermatology clinics, or female employees of MSKCC. There will be no follow-up visits (after baseline) for participants in the comparator cohort.	Behavioral: Questionnaires; Other: Clinical Assessments; Other: Saliva sample; (only once, preferably at baseline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of persistent alopecia	as assessed clinically and by phototrichogram assessments, among women exposed to cytotoxic chemotherapy	1 year
Incidence of alopecia	as assessed clinically and by phototrichogram assessments, among women exposed to endocrine therapies	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: University of Chicago; New York University
• Investigators: Principal Investigator: Alina Markova, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimated): August 20, 2015

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Alopecia; Skin Aging; Nail Changes; Hair Changes; 15-198
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 15-198