Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer
- Study type
- Clinical trial
- Study name
- SCALP
- Design
- Randomised multicentre clinical trial (7 centres in the United States) with assessment by a physician unaware of the treatment group; the reported data are from an interim analysis
- Sample size
- 182 patients randomised; 142 patients evaluable at the interim analysis
- Source
- JAMA · 2017
- Trial registration
- NCT01986140
In plain words
Hair loss is a well-known side effect of chemotherapy. In this study, women with breast cancer who were having chemotherapy were randomly assigned to use or not use a device that cools the scalp. After four cycles of chemotherapy, about half of the women who used the device (50.5%) had lost less than half of their hair, while no one in the group without the device had this result. Side effects from the device were mild to moderate, but its long-term effects still need to be studied.
Key results
Treatment arms and regimens
119 patients; scalp cooling with the PAXMAN Orbis device (cooling cap) during chemotherapy sessions. The intervention is a device and involves no drug.
Chemotherapy (in both groups) was one of the protocol's permitted regimens, at least 4 cycles at full dose: doxorubicin 60 mg/m² with cyclophosphamide 600 mg/m²; epirubicin 90 to 100 mg/m² with cyclophosphamide 600 mg/m²; doxorubicin 50 mg/m² with fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m²; paclitaxel 80 to 90 mg/m² weekly (one cycle every 3 weeks) or 175 mg/m² every 2 to 3 weeks alone; docetaxel 100 mg/m² alone; docetaxel 75 to 100 mg/m² with pertuzumab and trastuzumab at standard doses; docetaxel 75 mg/m² with cyclophosphamide 600 mg/m²; or docetaxel 75 mg/m² with carboplatin AUC 6 and trastuzumab at standard dose. Concurrent trastuzumab and pertuzumab and dose-dense schedules were allowed.
63 patients; no scalp cooling or other intervention to prevent hair loss, with the same permitted protocol chemotherapy regimens (taxane, anthracycline or both sequentially).
Source of the regimen details: ClinicalTrials.gov NCT01986140 (device, permitted chemotherapy regimens and doses) and the abstract of the paper; device intervention without a drug. Pre-cooling time, cap temperature and post-infusion cooling time are not stated in these sources
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Women under 70 years with newly diagnosed stage 1 to 2 breast cancer for whom at least 4 cycles of full-dose anthracycline- or taxane-based neoadjuvant or adjuvant chemotherapy with curative intent were planned; normal TSH in the past year and, if diabetic, normal HbA1c in the past 3 months. Exclusion criteria: stage 3 or 4 or another concurrent malignancy, baseline alopecia (grade above 0), cold agglutinin disease or cold urticaria, myeloablative chemotherapy and concurrent anthracycline and taxane (AT or TAC). Enrolment from 9 December 2013 to 30 September 2016. Mean (SD) age of evaluable patients was 52.6 (10.1) years; 36% (51 patients) received anthracycline-based and 64% (91 patients) taxane-based chemotherapy.
Endpoints
Primary efficacy endpoints: successful hair preservation by CTCAE version 4.0 at the end of 4 chemotherapy cycles, assessed by a physician unaware of the treatment group (grade 0 [no hair loss] or grade 1 [loss of less than 50% of hair not requiring a wig] counted as hair preservation), and device safety.
Secondary endpoints: wig use and scores on the EORTC QLQ-C30, the Hospital Anxiety and Depression Scale (HADS) and a summary scale from the Body Image Scale.
Safety and side effects
Only adverse events related to device use were recorded. In the cooling group, 54 adverse events were reported, all grade 1 and 2. No serious device-related adverse events were reported.
Clinical significance and place in guidelines
This trial provides the first randomised evidence on the efficacy of a scalp cooling device in reducing chemotherapy-induced (taxane or anthracycline) alopecia in women with stage 1 to 2 breast cancer. According to the abstract, further research is needed to assess longer-term efficacy and adverse effects. The place of this method in clinical guidelines and its regulatory status should be checked separately.
Limitations
The reported data are from an interim analysis, and the study was stopped early for superiority. The efficacy analysis was in 142 evaluable participants of 182 randomised patients. Only adverse events related to device use were collected. According to the authors, longer-term efficacy and adverse effects need to be studied.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.