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
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
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
Parallel
cryotherapy for chemotherapy-induced madarosis
DeviceApplication 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.
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)
Eyelash hair preservation rate
Proportion of patients with ≤50% eyelash hair loss (Grade 0-2 on CTCAE v5.0 adapted
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)
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)\*
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."
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