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NCT06955702
Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients
NA trial testing cryotherapy for chemotherapy-induced madarosis in Breast Neoplasms in 120 participants. Currently enrolling.
31 July 2025
Quick facts
| Lead sponsor | University of Salamanca |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 15 November 2023 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 August 2026 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- cryotherapy for chemotherapy-induced madarosis
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Alopecia — all drugs for Alopecia →
- Madarosis — all drugs for Madarosis →
- Eyebrow Diseases — all drugs for Eyebrow Diseases →
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):
-
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:
- PubMed search for NCT06955702
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06955702 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Salamanca
- Last refreshed: 22 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06955702.
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