Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

cryotherapy for chemotherapy-induced madarosis: 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 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

Primary outcome measure(s)

• Eyebrow hair preservation rate — 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)

Trial sites (2)

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