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

Non-Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02530177
• Other study ID #: 15-198
• Status: Active, not recruiting
• Start date: August 19, 2015
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 546
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Breast Neoplasms
• Non-Metastatic Breast Cancer

Intervention

Other:
• Clinical Assessments

Behavioral:
• Questionnaires

Other:
• Saliva sample
(only once, preferably at baseline)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of persistent alopecia	as assessed clinically and by phototrichogram assessments, among women exposed to cytotoxic chemotherapy	1 year
Primary	Incidence of alopecia	as assessed clinically and by phototrichogram assessments, among women exposed to endocrine therapies	1 year

External Links

•   Memorial Sloan Kettering Cancer Center