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

• ClinicalTrials.gov Identifier: NCT02530177
• Recruitment Status: Active, not recruiting
• First Posted: August 20, 2015
• Last Update Posted: December 1, 2022
• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: University of Chicago; New York University
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: August 19, 2015
• First Posted Date: August 20, 2015
• Last Update Posted Date: December 1, 2022
• Study Start Date: August 19, 2015
• Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2015)

• Incidence of persistent alopecia [ Time Frame: 1 year ]
  as assessed clinically and by phototrichogram assessments, among women exposed to cytotoxic chemotherapy
• Incidence of alopecia [ Time Frame: 1 year ]
  as assessed clinically and by phototrichogram assessments, among women exposed to endocrine therapies

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

saliva (baseline only)

• Sampling Method: Non-Probability Sample
• Study Population: MSKCC clinics
• Condition: Non-Metastatic Breast Cancer

Intervention

• Other: Clinical Assessments
• Behavioral: Questionnaires
• Other: Saliva sample
  (only once, preferably at baseline)

Study Groups/Cohorts

• 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.
  Interventions:

  • Other: Clinical Assessments
  • Behavioral: Questionnaires
  • Other: Saliva sample
• 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.
  Interventions:

  • Other: Clinical Assessments
  • Behavioral: Questionnaires
  • Other: Saliva sample
• 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.
  Interventions:

  • Other: Clinical Assessments
  • Behavioral: Questionnaires
  • Other: Saliva sample

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 20, 2020): 546
• Original Estimated Enrollment (submitted: August 19, 2015): 700
• Estimated Study Completion Date: August 2023
• Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02530177
• Other Study ID Numbers: 15-198
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Memorial Sloan Kettering Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Memorial Sloan Kettering Cancer Center
• Original Study Sponsor: Same as current

Collaborators

• University of Chicago
• New York University

Investigators

• Principal Investigator: Mario Lacouture, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: November 2022