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

Plain Language Summary

Simplified for easier understanding

This study tests whether wearing a scalp cooling cap during chemotherapy can also prevent eyelash and eyebrow loss (called madarosis) in women with breast cancer. Hair loss from chemotherapy can be distressing, and while scalp cooling has been studied for head hair, less is known about its effect on facial hair. **You may be eligible if...** - You are a woman aged 18 or older with newly diagnosed breast cancer (any stage) - You are about to begin your first course of chemotherapy using anthracyclines and/or taxanes - You have not had any prior cancer treatment **You may NOT be eligible if...** - You have had previous chemotherapy, hormone therapy, or immunotherapy for breast cancer - You already had eyebrow or eyelash loss before starting treatment - You have had radiation to your brain or skull in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.