Actively Recruiting
Effect of Cryotherapy in the Prevention of Alopecia in Eyebrows and Eyelashes in Breast Cancer Patients Treated With Anthracyclines and Taxanes
Led by University of Salamanca · Updated on 2025-05-22
120
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chemotherapy-induced alopecia (CIA) can deeply affect body image in breast cancer patients, especially when it causes loss of eyebrows and eyelashes, known as madarosis. This research evaluates whether targeted cryotherapy applied to the eyebrow area can help reduce madarosis caused by anthracycline- and taxane-based chemotherapy. The study aims to fill a gap in supportive cancer care by developing the first evidence-based protocol for madarosis prevention and creating a new alopecia classification scale. The study involves two groups: one receiving targeted supraorbital cryotherapy using temperature-controlled cold devices applied 15 minutes before chemotherapy infusion and continued for 20 minutes after, and a control group receiving chemotherapy without cryotherapy. Chemotherapy includes anthracyclines and taxanes, following standard treatment protocols. Cryotherapy is delivered via cold eye masks positioned over the eyebrow area during treatment. Participants will be assessed at four times: before treatment, mid-chemotherapy, at chemotherapy completion, and one month after finishing treatment. Hair retention will be measured using photogrammetric analysis with AI-powered algorithms. Quality of life and patient satisfaction with eyelash appearance will be evaluated through validated questionnaires. Adverse events related to cryotherapy will also be monitored throughout chemotherapy, which typically lasts about 20 to 24 weeks.
CONDITIONS
Brief Title
Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Newly diagnosed breast cancer at any stage
- Scheduled to receive anthracycline- and/or taxane-based chemotherapy as first-line systemic treatment
- No prior history of antineoplastic treatment
- Able and willing to provide written informed consent
You will not qualify if you...
- Patients with recurrent breast cancer who have previously received hormone therapy, chemotherapy, or immunotherapy
- Presence of alopecia before starting cancer treatment
- History of cerebral radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 to 24 weeks
Participants receive supraorbital cryotherapy using temperature-controlled devices applied before and during chemotherapy infusion to prevent eyebrow and eyelash hair loss.
Repeated treatment visits concurrent with chemotherapy sessions
Duration - 1 month post-chemotherapy completion
Participants are followed for hair preservation assessment, quality of life questionnaires, and monitoring of cryotherapy-related adverse events after chemotherapy completion.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39011
Actively Recruiting
2
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
Research Team
M
Marta González Fernández-Conde, PhD Nursing
A
Aline Rodrigues Françoso, PhD Nursing
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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