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

NCT02530177 | Active Not Recruiting

• 1 other identifier: 15-198
• Study Type: observational
• Target: 546
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Metastatic Breast Cancer

Keywords

Alopecia; Skin Aging; Nail Changes; Hair Changes; 15-198

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Other: Clinical Assessments; Behavioral: Questionnaires; Other: Saliva sample

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.

Other: Clinical Assessments; Behavioral: Questionnaires; Other: Saliva sample

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.

Other: Clinical Assessments; Behavioral: Questionnaires; Other: Saliva sample

Interventions

Clinical Assessments OTHER

COMPARATOR (menopausal women); Patients having CYTOTOXIC CHEMOTHERAPY; Patients having ENDOCRINE THERAPY

Questionnaires BEHAVIORAL

COMPARATOR (menopausal women); Patients having CYTOTOXIC CHEMOTHERAPY; Patients having ENDOCRINE THERAPY

Saliva sample OTHER

(only once, preferably at baseline)

COMPARATOR (menopausal women); Patients having CYTOTOXIC CHEMOTHERAPY; Patients having ENDOCRINE THERAPY

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Chicago: collaborator
• New York University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

saliva (baseline only)

MeSH Terms

Conditions

Alopecia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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

• Alina Markova, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: August 19, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)