Effect of Cryotherapy in the Prevention of Alopecia in Eyebrows and Eyelashes in Breast Cancer Patients Treated With Anthracyclines and Taxanes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Spain
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Marqués de Valdecilla
RECRUITING
Santander
Contact Information
Primary
Marta González Fernández-Conde, PhD Nursing
martagfc@usal.es
661544179
Backup
Aline Rodrigues Françoso, PhD Nursing
arodrigues@saludcastillayleon.es
645182581
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 120
Treatments
Experimental: Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes)
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.
No_intervention: Standard chemotherapy (no cryotherapy)
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.
Sponsors
Leads: University of Salamanca

This content was sourced from clinicaltrials.gov