Active — Not RecruitingNot Applicable

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

United States546 participantsStarted 2015-08-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-ooph…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of persistent alopecia

Timeframe: 1 year

Incidence of alopecia

Timeframe: 1 year

Trial details

NCT IDNCT02530177

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Non-Metastatic Breast Cancer trials