Clinical trial · Interventional
Scalp Cooling to Prevent Chemo-induced Hair Loss
Scalp Cooling for Alopecia Prevention (SCALP)
NCT01986140CI-TRIAL-00052906SCALPunknownN/AResults postedClinicalTrials.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)
Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.
Conditions
Conditions (2)
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 | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control No treatment | Other | — | UNRESOLVED |
| PAXMAN Orbis Scalp Cooler | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PAXMAN Orbis Scalp Cooler
- description
- Scalp Cooling
- interventionNames
- Device: PAXMAN Orbis Scalp Cooler
- type
- OTHER
- label
- Control No treatment
- description
- Control
- interventionNames
- Other: Control No treatment
Primary outcomes (1)
- measure
- Hair Preservation
- timeFrame
- 4 to 8 Months
- description
- The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosis of breast cancer stage 1-2 * Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent * Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen, * Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses * Concurrent traztuzumab at standard doses is allowed * Concurrent pertuzumab at standard doses is allowed * Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated. * Subjects must have TSH collected within 1 year prior to treatment and found within normal range. * If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits. * CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits. Exclusion Criteria: * Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) * Baseline alopecia (defined CTCAE v4.0 grade \> 0, see appendix B for CTCAE v4.0 scale) * Subjects with cold agglutinin disease or cold urticaria * Subjects who are scheduled for bone marrow ablation chemotherapy * Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC) * Male gender * Age \>= 70 years
References
Publications (2)
- DERIVEDChevli N, Wang K, Haque W, Schwartz MR, Nangia J, Sasaki J, Farach AM, Hatch SS, Butler EB, Teh BS. Prognostic Impact of Radiation Therapy in Pure Mucinous Breast Carcinoma. Clin Breast Cancer. 2022 Oct;22(7):e807-e817. doi: 10.1016/j.clbc.2022.06.005. Epub 2022 Jul 7. PMID 35915020
- DERIVEDNangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939. PMID 28196254