Clinical trial · Interventional
Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)
Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
NCT03711877CI-TRIAL-00055261COHAIRunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a phase III, single-center, prospective, open-label, randomized,controlled study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold cap | Device | — | UNRESOLVED |
| Scalp cooling system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- scalp cooling system
- description
- 'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.
- interventionNames
- Device: Scalp cooling system
- type
- ACTIVE_COMPARATOR
- label
- cold cap
- description
- 'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
- interventionNames
- Device: Cold cap
Primary outcomes (1)
- measure
- The effects on the prevention of alopecia of two methods
- timeFrame
- One year after neoadjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients, 18≦age ≦66 years * Invasive breast cancer diagnosed with core needle needle biopsy * Staging I-II * Without chemotherapy contraindications, and planned to receive neoadjuvant chemotherapy with a standard regimen (containing 4-cycle dose-dense anthracycline followed 4-cycle paclitaxel) * Attend the study voluntarily, sign the informed consent Exclusion Criteria: * History of malignant tumors * With chemotherapy contraindications * With severe dermatosis and severe sparsity * History of chronic diseases such as cerebrovascular disease, migraine and hyperthyroidism * Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection * Refuse to join the study
References
Publications (1)
- DERIVEDZhang J, Wang L, He Y, Sun H, Niu J, Duan M, Miao C, Li J, Cao W, Wang X, Wang X, Yang Y, Fan Z, Yu X. Efficacy of scalp cooling system versus chemical cooling cap in preventing chemotherapy-induced alopecia in breast cancer (COHAIR Study): a prospective randomized trial. Breast. 2026 Jun;87:104784. doi: 10.1016/j.breast.2026.104784. Epub 2026 Apr 2. PMID 41955993