RecruitingNot ApplicableNCT06955702

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

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

Sponsor

University of Salamanca

Enrollment

120 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Alopecia Madarosis Eyebrow Diseases Eyelash Diseases Anthracyclines Taxoids Side Effects

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria3

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

Interventions

DEVICEcryotherapy 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.