Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
Recruiting · NCT06955702 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Salamanca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
2 locations listed.
- Hospital Marqués de Valdecilla - Santander, Cantabria, Spain
- Hospital Universitario de Salamanca - Salamanca, Salamanca, Spain