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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Non-Metastatic Breast Cancer

Treatments: Behavioral: Questionnaires; Other: Saliva sample; Other: Clinical Assessments

Study type: Observational

Funder types: Other

Identifiers

NCT02530177

15-198

Details and patient eligibility

About

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.

Enrollment: 546 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

546 participants in 3 patient groups

Patients having CYTOTOXIC CHEMOTHERAPY

Description:

Participants will undergo study related assessments and the appropriate HRQoL questionnaires will be administered. Baseline and follow-up clinical assessments will be performed, preferably when the patient presents to the clinic for (clinically indicated) standard-of-care visits. Initially, these visits will be coinciding with the appropriate chemotherapy dosing cycles (as applicable to select study cohorts), and subsequently they will be performed during the standard-of-care follow-up visits.

Treatment:

Other: Clinical Assessments

Other: Saliva sample

Behavioral: Questionnaires

Patients having ENDOCRINE THERAPY

Description:

Participants will undergo study related assessments and Medical and Personal History Questionnaire data collection forms and the appropriate HRQoL questionnaires, will be administered. Baseline and follow-up clinical assessments will be performed, preferably when the patient presents to the clinic for standard-of-care visits. Initially, these visits will be coinciding with the appropriate therapy and subsequently they will be performed during the standard-of-care follow-up visits.

Treatment:

Other: Clinical Assessments

Other: Saliva sample

Behavioral: Questionnaires

COMPARATOR (menopausal women)

Description:

Menopausal women will include unrelated visitors accompanying breast cancer patients (e.g. friends) attending the breast medicine or dermatology clinics, or female employees of MSKCC. There will be no follow-up visits (after baseline) for participants in the comparator cohort.

Treatment:

Other: Clinical Assessments

Other: Saliva sample

Behavioral: Questionnaires