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NCT02530177

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

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

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Record History

All 21 versions: 12 with changes below, 9 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Aug 2026 to Aug 2027
    • Eligibility criteria expanded, about 20 words
  2. Notable Primary and study completion dates: Aug 2024 to Aug 2026v18
  3. Notable Primary and study completion dates: Aug 2023 to Aug 2024v17
  4. Notable Primary and study completion dates: Aug 2021 to Aug 2023v14
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 700 to 546
    • Site details revised
    v13
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Primary and study completion dates: Aug 2019 to Aug 2021v11
  2. Notable Primary and study completion dates: Aug 2018 to Aug 2019v10
  3. Notable Eligibility criteria expanded, about 18 words
    • Study completion date: Aug 2018
    • Start date: Aug 2015 to Aug 19, 2015
    v6
  4. Notable Eligibility criteria shortened, about 20 wordsv5
  5. Notable Eligibility criteria shortened, about 11 wordsv4
  6. Notable Eligibility criteria expanded, about 1 word
    • Interventions: Clinical Assessments (Other), Questionnaires (Behavioral), Salvia sample (Other) to Clinical Assessments (Other), Questionnaires (Behavioral), Saliva sample (Other)
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of persistent alopecia
Timeframe: 1 year
Incidence of alopecia
Timeframe: 1 year

Arms and interventions

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.

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.

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, Saliva sample

Behavioral: Questionnaires

Sites

1 site in 1 country

  • Memorial Sloan Kettering Cancer CenterNew York, New York, United States