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NCT06955702

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

Recruiting now NA Last updated 22 May 2025
What this trial tests

NA trial testing cryotherapy for chemotherapy-induced madarosis in Breast Neoplasms in 120 participants. Currently enrolling.

Timeline
15 November 2023
Primary endpoint
31 July 2025
31 August 2026

Quick facts

Lead sponsorUniversity of Salamanca
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment120
Start date15 November 2023
Primary completion31 July 2025
Estimated completion31 August 2026
Sites2 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

University of Salamanca

Who can join

18 and older, female only, with Breast Neoplasms or Alopecia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Objective quantification of chemotherapy-induced madarosis: a pilot study of an automated computer vision pipeline for eyebrow density assessment.
    González M, Sahila A, Rodrigues A, Bernardo P, et al · · 2026 · PMID 41975023 · DOI 10.1038/s41598-026-48967-5

Verify or expand the search:

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

Other University of Salamanca trials

Trials by the same sponsor.

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Data sources for this page

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