ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02530177
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : December 2, 2017
Sponsor:
Collaborators:
University of Chicago
New York University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Non-Metastatic Breast Cancer Other: Clinical Assessments Behavioral: Questionnaires Other: Saliva sample

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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 Start Date : August 19, 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients having CYTOTOXIC CHEMOTHERAPY
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.
Other: Clinical Assessments Behavioral: Questionnaires Other: Saliva sample
(only once, preferably at baseline)
Patients having ENDOCRINE THERAPY
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.
Other: Clinical Assessments Behavioral: Questionnaires Other: Saliva sample
(only once, preferably at baseline)
COMPARATOR (menopausal women)
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.
Other: Clinical Assessments Behavioral: Questionnaires Other: Saliva sample
(only once, preferably at baseline)



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
saliva (baseline only)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
MSKCC clinics
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530177


Contacts
Contact: Mario Lacouture, MD 646-888-6014
Contact: Shari Goldfarb, MD 646-888-5080

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Mario Lacouture, MD    646-888-6014      
Contact: Shari Goldfarb, MD    646-888-5080      
Principal Investigator: Mario Lacouture, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Chicago
New York University
Investigators
Principal Investigator: Mario Lacouture, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02530177     History of Changes
Other Study ID Numbers: 15-198
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Alopecia
Skin Aging
Nail Changes
Hair Changes
15-198

Additional relevant MeSH terms:
Breast Neoplasms
Alopecia
Alopecia Areata
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical