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

RecruitingNAAges 18 Years - anyFemaleUniversity of Salamanca
NCT06955702 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • cryotherapy for chemotherapy-induced madarosis
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Where

2 sites
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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