Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02530177

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Non-Metastatic Breast Cancer Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinical assessments

Other

Questionnaires

Behavioral

Saliva Sample

Other

(only once, preferably at baseline)

Primary outcomes

  1. Incidence of persistent alopecia

    Time frame: 1 year

    as assessed clinically and by phototrichogram assessments, among women exposed to cytotoxic chemotherapy

  2. Incidence of alopecia

    Time frame: 1 year

    as assessed clinically and by phototrichogram assessments, among women exposed to endocrine therapies

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • New York University
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2015
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.