Non-Metastatic Breast Cancer
Conditions
Keywords
Alopecia, Skin Aging, Nail Changes, Hair Changes, 15-198
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.
Interventions
OTHERClinical Assessments
BEHAVIORALQuestionnaires
OTHERSaliva sample
(only once, preferably at baseline)
Sponsors
University of Chicago
New York University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of persistent alopecia | 1 year | as assessed clinically and by phototrichogram assessments, among women exposed to cytotoxic chemotherapy |
| Incidence of alopecia | 1 year | as assessed clinically and by phototrichogram assessments, among women exposed to endocrine therapies |
Countries
United States
Outcome results
None listed