Breast NeoplasmsNCT06955702
Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
A study testing cryotherapy for chemotherapy-induced madarosis in people with Breast Neoplasms and Alopecia, run by University of Salamanca at 2 sites in Spain.
Trial summary
Chemotherapy-induced alopecia (CIA) significantly compromises body image in breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cooling devices are routinely employed to prevent scalp alopecia, no standardized interventions exist for madarosis prevention. 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
- Breast Neoplasms, Alopecia, Madarosis
- What is being tested?
- cryotherapy for chemotherapy-induced madarosis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Nov 2023to 31 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Female participants aged ≥18 years
- Newly diagnosed breast cancer (any stage)
- Scheduled to receive anthracycline- and/or taxane-based chemotherapy as first-line systemic treatment
- No prior history of antineoplastic treatment
- Willing and able to provide written informed consent
Who cannot join
- Patients with recurrent disease who have received prior hormone therapy, chemotherapy, and/or immunotherapy
- Presence of alopecia prior to the initiation of cancer treatment
- History of cerebral radiotherapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Marta González Fernández-Conde, 661544179, martagfc@usal.es
Aline Rodrigues Françoso, 645182581, arodrigues@saludcastillayleon.es
- Recruiting
Hospital Marqués de Valdecilla
Santander, Cantabria, 39011
Marta González Fernández-Conde, PhD Nursing, 661544179, martagfc@usal.es
Patricia Bernardo Heras, RN, 691184614, pattberh@gmail.com
About this study
Official title: Effect of Cryotherapy in the Prevention of Alopecia in Eyebrows and Eyelashes in Breast Cancer Patients Treated With Anthracyclines and Taxanes
Chemotherapy-induced alopecia (CIA) significantly compromises body image in breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cooling devices are routinely employed to prevent scalp alopecia, no standardized interventions exist for madarosis prevention. This quasi-experimental study assesses the efficacy of targeted eyebrow cryotherapy in reducing anthracycline- and taxane-induced madarosis.
The trial will enroll patients from two tertiary hospitals in Salamanca (intervention arm: cryotherapy) and a control cohort from Santander. Cryotherapy will be administered (-4°C to -7°C) 15 minutes pre-chemotherapy infusion and maintained for 20 minutes post-infusion. Primary outcomes include hair retention quantified through photogrammetric analysis (TIDOP Research Group) at four timepoints: baseline, mid-treatment, chemotherapy completion, and 1-month follow-up. Secondary endpoints evaluate quality of life (QLQ-C30 validated scales) and cryotherapy-related adverse events (CTCAE v5.0 criteria).
This investigation aims to establish the first evidence-based protocol for madarosis prevention and develop a novel alopecia classification scale, addressing a critical gap in supportive oncology care
Read the detailed description
Background: Chemotherapy-induced alopecia (CIA) is one of the most distressing adverse effects for breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cryotherapy has demonstrated efficacy in reducing CIA, no standardized protocols exist for preventing madarosis. Preliminary studies suggest localized cryotherapy may mitigate this effect but robust evidence is lacking.
Objectives: The primary objective is to evaluate the efficacy of supraorbital cryotherapy in preventing anthracycline- or taxane-induced madarosis in breast cancer patients. Secondary objectives include: (1) Quantifying chemotherapy-induced alopecia of eyebrows (madarosis) and eyelashes (milphosis) in control groups, (2) developing a novel alopecia classification scale for eyebrows and eyelashes (currently nonexistent), (3) assessing quality-of-life impact using validated questionnaires "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)" and, and Eyelash Satisfaction Questionnaire (ESQ). (4) monitoring cryotherapy-related adverse events (e.g., headache, localized pain).
Methodology: This non-randomized, quasi-experimental multicenter trial will be conducted at hospitals in Salamanca and Santander. The study population will comprise 120 breast cancer patients receiving anthracycline/taxane-based chemotherapy (sample size may be adjusted based on recruitment). Inclusion criteria: women >18 years old with recent diagnosis and no prior treatments. The intervention group will receive supraorbital cryotherapy using temperature-controlled devices (-4°C to -7°C) applied 15 minutes before chemotherapy infusion and maintained for 20 minutes post-infusion.
Outcome Measures: Primary outcomes will be assessed via:
- Photogrammetric analysis (TIDOP Research Group) at four timepoints: baseline, mid-treatment, end-of-treatment, and 1-month follow-up. Hair retention will be quantified using automated AI algorithms (DAM-Net).
- Patient-reported outcomes using the EORTC QLQ-BR23 and ESQ questionnaires.
- Adverse event monitoring through ad hoc surveys. Statistical Analysis: Data will be analyzed using ANOVA and Mann-Whitney tests for intergroup comparisons, Pearson/Spearman correlations for continuous variables, and linear regression to identify predictive factors.
Ethics: The study has been approved by the Ethics Committees of Salamanca Health Area (Ref: 2023 09 1427) and Hospital Universitario Marqués de Valdecilla (Cantabria, Spain)" (Ref: 2024.459). All participants will provide written informed consent in accordance with the Helsinki Declaration and "General Data Protection Regulation (GDPR)".
Limitations: Current evidence on madarosis/milphosis is limited, and no validated scales exist for grading eyebrow/eyelash alopecia.
Innovations: This study introduces: (1) the first classification scale for chemotherapy-induced madarosis, (2) evidence for cryotherapy as a preventive intervention, and (3) an objective AI-powered photogrammetry methodology.
- Conditions
- Breast Neoplasms, Alopecia, Madarosis, Eyebrow Diseases, Eyelash Diseases, Anthracyclines
- Being tested
- cryotherapy for chemotherapy-induced madarosis
- Keywords
- Chemotherapy-induced alopecia, Madarosis, Eyebrow preservation, Taxane-induced alopecia, Anthracycline-induced alopecia, Cryotherapy, Supportive care in oncology, Quality of life, Scalp cooling, Patient-reported outcomes
- Medical subject headings
- Breast Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy for chemotherapy-induced madarosisDevice
Application of temperature-controlled cold devices (-4°C to -7°C) to the supraorbital area (up to 3 cm above the eyelid margin), administered 15 minutes before chemotherapy infusion and maintained for 20 minutes post-infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes) | Experimental | Cryotherapy is administered via thermally regulated cold eye masks (-10°C ± 2°C) positioned over the supraorbital region, with application commencing 15 minutes pre-chemotherapy and continuing through the infusion period plus 20 minutes post-administration. Chemotherapy includes anthracyclines (doxorubicin/epirubicin) and/or taxanes (paclitaxel/docetaxel) per standard protocols. Receives: Device: cryotherapy for chemotherapy-induced madarosis |
| Standard chemotherapy (no cryotherapy) | No intervention | Patients receive anthracycline/taxane-based chemotherapy per institutional protocols without application of cold eye masks or any cryotherapy intervention. All other supportive care measures match the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyebrow hair preservation rate
Proportion of patients with ≤50% eyebrow hair loss (Grade 0-2 on CTCAE v5.0 adapted scale) at end of treatment, assessed via AI-based photogrammetry (TIDOP Group)
Measured: From baseline to 1 month post-chemotherapy completion
Secondary outcomes (6)
Eyelash hair preservation rate
Proportion of patients with ≤50% eyelash hair loss (Grade 0-2 on CTCAE v5.0 adapted
Measured: From baseline to 1 month post-chemotherapy completion
Control group madarosis incidence
Absolute reduction in eyebrow hair count (number of hairs lost) from baseline to end-of-treatment, measured via AI-based photogrammetry (DAM-Net)
Measured: From baseline to 1 month post-chemotherapy completion
Change in Body Image Score Measured by EORTC QLQ-BR23
Mean change in body image subscale score (Items 9-12) from baseline to 1-month post-chemotherapy. Items assess physical attractiveness, femininity, and body dissatisfaction using a 4-point Likert scale (1='Not at all' to 4='Very much'). Raw scores are linearly transformed to a 0-100 scale following EORTC guidelines, where higher scores indicate worse body image perception."*
Measure: *EORTC QLQ-BR23 (23-item breast cancer-specific module)*
Measured: From baseline to 1 month post-chemotherapy completion
Change in Eyelash Satisfaction measured by Eyelash Satisfaction Questionnaire (ESQ)
Measure: Eyelash Satisfaction Questionnaire (ESQ)
Description:
Change in eyelash-related satisfaction assessed through three validated domains of the 23-item ESQ:
- LFOS (Length, Fullness, Overall Satisfaction): 6 items (Q1-Q6) scored 1-5. Raw sum range: 3-15. Lower scores = Better satisfaction
- CAP (Confidence, Attractiveness, Professionalism): 7 items (Q16-Q19, Q21-Q23) scored 1-5. Raw sum range: 3-15. Lower scores = Better self-perception
- DR (Daily Routine): 4 items (Q12-Q15) scored 1-5. Raw sum range: 3-15. Higher scores = Better daily adaptation All items use 5-point Likert scales (1='Very dissatisfied' to 5='Very satisfied'). Scores analyzed as untransformed raw sums per domain."
Measured: From baseline to 1 month post-chemotherapy completion
Cryotherapy-related adverse events
Proportion of patients reporting side effects assessed via a non-validated *ad hoc* questionnaire (Not at all, a little, quite a bit, very much) developed specifically for this study due to lack of validated tools in the literature
Measured: From baseline through chemotherapy completion (approximately 20 to 24 weeks)
Proposal of a new madarosis classification scale
Development of an automated madarosis grading system through:
- Standardized dual-camera imaging: Paired Canon EOS700D (60mm lenses, 1.5m, auto-mode) capturing eyebrow/eyelash regions.
- Iterative AI pipeline (Python-based):
- Phase 1: Temporal alignment via anthropometric landmarks. Deep Learning refinement
- Phase 2: Pixel-wise hair detection (DAM-Net-class models)
- Phase 3: Density change analysis
- Validation: Against untreated control images Covers most alopecia-inducing drugs in breast cancer (anthracyclines/taxanes). Baseline, post-cycles (anthra:4; pacli:8; docet:4), 1mo post-tx. Additional assessments if n≥30: paclitaxel (12 cycles), docetaxel (6 cycles).
Open-source release planned.
Measured: Baseline, after cycles (anthracyclines:4; paclitaxel:8/12*; docetaxel:4/6*), 1mo post-treatment. *if n≥30. Duration: ~1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start15 Nov 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental parallel design comparing cryotherapy vs. standard care in two separate patient groups.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta González Fernández-Conde, University of Salamanca
- Investigators
- Marta González Fernández-Conde, Principal investigator, Universidad Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955702
- Sponsor's protocol ID
- PC_TCUE23-24_033
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotherapy in the Prevention of Alopecia in Eyebrows and Eyelashes in Breast Cancer Patients Treated With Anthracyclines and Taxanes
- ClinicalTrials.gov ID
- NCT06955702
- Acronym / sponsor ID
- PC_TCUE23-24_033
- Conditions
- Breast Neoplasms, Alopecia, Madarosis, Eyebrow Diseases, Eyelash Diseases, Anthracyclines
- Keywords
- Chemotherapy-induced alopecia, Madarosis, Eyebrow preservation, Taxane-induced alopecia, Anthracycline-induced alopecia, Cryotherapy, Supportive care in oncology, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- 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.
Chemotherapy-induced alopecia (CIA) significantly compromises body image in breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cooling devices are routinely employed to prevent scalp alopecia, no standardized interventions exist for madarosis prevention. This quasi-experimental study assesses the efficacy of targeted eyebrow cryotherapy in reducing anthracycline- and taxane-induced madarosis.
The trial will enroll patients from two tertiary hospitals in Salamanca (intervention arm: cryotherapy) and a control cohort from Santander. Cryotherapy will be administered (-4°C to -7°C) 15 minutes pre-chemotherapy infusion and maintained for 20 minutes post-infusion. Primary outcomes include hair retention quantified through photogrammetric analysis (TIDOP Research Group) at four timepoints: baseline, mid-treatment, chemotherapy completion, and 1-month follow-up. Secondary endpoints evaluate quality of life (QLQ-C30 validated scales) and cryotherapy-related adverse events (CTCAE v5.0 criteria).
This investigation aims to establish the first evidence-based protocol for madarosis prevention and develop a novel alopecia classification scale, addressing a critical gap in supportive oncology care
Detailed description
Background: Chemotherapy-induced alopecia (CIA) is one of the most distressing adverse effects for breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cryotherapy has demonstrated efficacy in reducing CIA, no standardized protocols exist for preventing madarosis. Preliminary studies suggest localized cryotherapy may mitigate this effect but robust evidence is lacking.
Objectives: The primary objective is to evaluate the efficacy of supraorbital cryotherapy in preventing anthracycline- or taxane-induced madarosis in breast cancer patients. Secondary objectives include: (1) Quantifying chemotherapy-induced alopecia of eyebrows (madarosis) and eyelashes (milphosis) in control groups, (2) developing a novel alopecia classification scale for eyebrows and eyelashes (currently nonexistent), (3) assessing quality-of-life impact using validated questionnaires "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)" and, and Eyelash Satisfaction Questionnaire (ESQ). (4) monitoring cryotherapy-related adverse events (e.g., headache, localized pain).
Methodology: This non-randomized, quasi-experimental multicenter trial will be conducted at hospitals in Salamanca and Santander. The study population will comprise 120 breast cancer patients receiving anthracycline/taxane-based chemotherapy (sample size may be adjusted based on recruitment). Inclusion criteria: women >18 years old with recent diagnosis and no prior treatments. The intervention group will receive supraorbital cryotherapy using temperature-controlled devices (-4°C to -7°C) applied 15 minutes before chemotherapy infusion and maintained for 20 minutes post-infusion.
Outcome Measures: Primary outcomes will be assessed via:
- Photogrammetric analysis (TIDOP Research Group) at four timepoints: baseline, mid-treatment, end-of-treatment, and 1-month follow-up. Hair retention will be quantified using automated AI algorithms (DAM-Net).
- Patient-reported outcomes using the EORTC QLQ-BR23 and ESQ questionnaires.
- Adverse event monitoring through ad hoc surveys. Statistical Analysis: Data will be analyzed using ANOVA and Mann-Whitney tests for intergroup comparisons, Pearson/Spearman correlations for continuous variables, and linear regression to identify predictive factors.
Ethics: The study has been approved by the Ethics Committees of Salamanca Health Area (Ref: 2023 09 1427) and Hospital Universitario Marqués de Valdecilla (Cantabria, Spain)" (Ref: 2024.459). All participants will provide written informed consent in accordance with the Helsinki Declaration and "General Data Protection Regulation (GDPR)".
Limitations: Current evidence on madarosis/milphosis is limited, and no validated scales exist for grading eyebrow/eyelash alopecia.
Innovations: This study introduces: (1) the first classification scale for chemotherapy-induced madarosis, (2) evidence for cryotherapy as a preventive intervention, and (3) an objective AI-powered photogrammetry methodology.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental parallel design comparing cryotherapy vs. standard care in two separate patient groups.
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes) | Experimental | Device: cryotherapy for chemotherapy-induced madarosisCryotherapy is administered via thermally regulated cold eye masks (-10°C ± 2°C) positioned over the supraorbital region, with application commencing 15 minutes pre-chemotherapy and continuing through the infusion period plus 20 minutes post-administration. Chemotherapy includes anthracyclines (doxorubicin/epirubicin) and/or taxanes (paclitaxel/docetaxel) per standard protocols. |
| Standard chemotherapy (no cryotherapy) | No intervention | –Patients receive anthracycline/taxane-based chemotherapy per institutional protocols without application of cold eye masks or any cryotherapy intervention. All other supportive care measures match the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged ≥18 years
- Newly diagnosed breast cancer (any stage)
- Scheduled to receive anthracycline- and/or taxane-based chemotherapy as first-line systemic treatment
- No prior history of antineoplastic treatment
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Patients with recurrent disease who have received prior hormone therapy, chemotherapy, and/or immunotherapy
- Presence of alopecia prior to the initiation of cancer treatment
- History of cerebral radiotherapy
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 |
|---|---|---|
| cryotherapy for chemotherapy-induced madarosisApplication of temperature-controlled cold devices (-4°C to -7°C) to the supraorbital area (up to 3 cm above the eyelid margin), administered 15 minutes before chemotherapy infusion and maintained for 20 minutes post-infusion. | Device | Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes) |
Primary outcome
Eyebrow hair preservation rate
Time frame: From baseline to 1 month post-chemotherapy completion
Proportion of patients with ≤50% eyebrow hair loss (Grade 0-2 on CTCAE v5.0 adapted scale) at end of treatment, assessed via AI-based photogrammetry (TIDOP Group)
6 secondary outcomes
Eyelash hair preservation rate
Time frame: From baseline to 1 month post-chemotherapy completion
Control group madarosis incidence
Time frame: From baseline to 1 month post-chemotherapy completion
Change in Body Image Score Measured by EORTC QLQ-BR23
Time frame: From baseline to 1 month post-chemotherapy completion
Change in Eyelash Satisfaction measured by Eyelash Satisfaction Questionnaire (ESQ)
Time frame: From baseline to 1 month post-chemotherapy completion
Cryotherapy-related adverse events
Time frame: From baseline through chemotherapy completion (approximately 20 to 24 weeks)
Proposal of a new madarosis classification scale
Time frame: Baseline, after cycles (anthracyclines:4; paclitaxel:8/12*; docetaxel:4/6*), 1mo post-treatment. *if n≥30. Duration: ~1 year
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 22 May 2025.
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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.
Marta González Fernández-Conde principal investigator
Universidad Salamanca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy for chemotherapy-induced madarosis in people with Breast Neoplasms and Alopecia, run by University of Salamanca at 2 sites in Spain.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Marta González Fernández-Conde, PhD Nursing (661544179, martagfc@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyebrow hair preservation rate (time frame: From baseline to 1 month post-chemotherapy completion). 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 22 May 2025.