Clinical trial NCT02530177: Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Metastatic Breast Cancer
Keywords: Alopecia
Skin Aging
Nail Changes
Hair Changes
15-198
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: New York University
First posted: 2015-08-20
Enrollment: 546
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of persistent alopecia
timeFrame: 1 year
measure: Incidence of alopecia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alina Markova, MD
role: PRINCIPAL_INVESTIGATOR
References: