Non-Metastatic Breast CancerNCT02530177
Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer
An observational study of Non-Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Metastatic Breast Cancer
- What is being tested?
- Clinical Assessments, Questionnaires and Saliva sample
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2015to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
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
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.
- Conditions
- Non-Metastatic Breast Cancer
- Being tested
- Clinical Assessments, Questionnaires, Saliva sample
- Keywords
- Alopecia, Skin Aging, Nail Changes, Hair Changes, 15-198
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical AssessmentsOther
QuestionnairesBehavioural
Saliva sampleOther
(only once, preferably at baseline)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Clinical Assessments; Behavioral: Questionnaires; Other: Saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of persistent alopecia
as assessed clinically and by phototrichogram assessments, among women exposed to cytotoxic chemotherapy
Measured: 1 year
Incidence of alopecia
as assessed clinically and by phototrichogram assessments, among women exposed to endocrine therapies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start19 Aug 2015
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, New York University
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530177
- Sponsor's protocol ID
- 15-198
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02530177
- Acronym / sponsor ID
- 15-198
- Conditions
- Non-Metastatic Breast Cancer
- Keywords
- Alopecia, Skin Aging, Nail Changes, Hair Changes, 15-198
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Chicago, New York University
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients having CYTOTOXIC CHEMOTHERAPY | – | Other: Clinical Assessments, Behavioral: Questionnaires, Other: Saliva sampleParticipants 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 | – | Other: Clinical Assessments, Behavioral: Questionnaires, Other: Saliva sampleParticipants 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) | – | Other: Clinical Assessments, Behavioral: Questionnaires, Other: Saliva sampleMenopausal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Assessments | Other | COMPARATOR (menopausal women), Patients having CYTOTOXIC CHEMOTHERAPY, Patients having ENDOCRINE THERAPY |
| Questionnaires | Behavioural | COMPARATOR (menopausal women), Patients having CYTOTOXIC CHEMOTHERAPY, Patients having ENDOCRINE THERAPY |
| Saliva sample(only once, preferably at baseline) | Other | COMPARATOR (menopausal women), Patients having CYTOTOXIC CHEMOTHERAPY, Patients having ENDOCRINE THERAPY |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Markova, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of persistent alopecia (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.