Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
| Anthracyclines | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Eyebrow Diseases | — | UNRESOLVED | — |
| Eyelash Diseases | — | UNRESOLVED | — |
| Madarosis | — | UNRESOLVED | — |
| Side Effects | — | UNRESOLVED | — |
| Taxoids | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryotherapy for chemotherapy-induced madarosis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes)
- description
- Cryotherapy is administered via thermally regulated cold eye masks (-10°C ± 2°C) positioned over the supraorbital region, with application commencing 15 minutes pre-chemotherapy and continuing through the infusion period plus 20 minutes post-administration. Chemotherapy includes anthracyclines (doxorubicin/epirubicin) and/or taxanes (paclitaxel/docetaxel) per standard protocols.
- interventionNames
- Device: cryotherapy for chemotherapy-induced madarosis
- type
- NO_INTERVENTION
- label
- Standard chemotherapy (no cryotherapy)
- description
- Patients receive anthracycline/taxane-based chemotherapy per institutional protocols without application of cold eye masks or any cryotherapy intervention. All other supportive care measures match the experimental group.
Primary outcomes (1)
- measure
- Eyebrow hair preservation rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available