Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer
- Study type
- Observational study
- Design
- Prospective cohort study at 5 US medical centres, with a control group without scalp cooling
- Sample size
- 122 patients (106 in the scalp cooling group and 16 in the control group; 14 were matched by age and chemotherapy regimen)
- Source
- JAMA · 2017
- Trial registration
- NCT01831024
In plain words
Hair loss is one of the most upsetting side effects of chemotherapy. In this study, women with early breast cancer who were having chemotherapy without an anthracycline used a device that keeps the scalp cold during treatment. About two thirds of these patients (66.3%) had lost 50% of their hair or less four weeks after finishing chemotherapy, while no one in the group without scalp cooling had this result. The side effects of the method were mild, such as a mild headache and feeling cold.
Key results
Treatment arms and regimens
Use of a scalp cooling system with chemotherapy. Cooling started 30 minutes before each chemotherapy cycle. Scalp temperature was kept at 3 °C (37 °F) throughout chemotherapy and for 90 to 120 minutes afterwards.
Chemotherapy without scalp cooling.
Chemotherapy regimens without combined or sequential anthracycline and taxane; doses not stated in the abstract.
Source of the regimen details: Abstract of the paper
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 with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy. Regimens containing sequential or combined anthracycline and taxane were excluded. Mean age was 53 years (range 28 to 77 years). 77.0% were White, 9.0% Black and 10.7% Asian. No participant in the scalp cooling group received an anthracycline.
Endpoints
Primary endpoint: hair loss self-estimated by the patient using the Dean scale 4 weeks after the last chemotherapy dose. Patients reviewed 5 photographs without blinding. A Dean score of 0 to 2 (loss of 50% or less) was defined as "treatment success". A positive association between scalp cooling and reduced hair loss was considered established if 50% or more of the scalp cooling group were successes and the lower bound of the 95% confidence interval was above 40%.
Secondary endpoints: quality of life at baseline, at the start of the last chemotherapy cycle and one month later. Median follow-up was 29.5 months.
Safety and side effects
Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced mild headache as an adverse event and 3 (2.8%) stopped scalp cooling because of feeling cold. The abstract does not report the rate of grade 3 or higher adverse events.
Clinical significance and place in guidelines
This study showed that scalp cooling in women receiving non-anthracycline chemotherapy for early breast cancer is associated with less hair loss and improves some quality-of-life measures. Given the design (cohort, not randomised) and the small control group, the findings should be interpreted with caution. Its effect with anthracycline-containing regimens, long-term hair loss and adverse effects need further research. Its place in clinical guidelines and its regulatory status should be checked separately; the abstract gives no information on them.
Limitations
The study was a non-randomised cohort study with a small control group (16 patients). Hair loss was estimated by the patients themselves, without blinding, by reviewing photographs. The primary assessment was 4 weeks after the last chemotherapy dose, and long-term hair loss was not assessed. Patients receiving anthracyclines were not enrolled. 101 of the 106 patients in the scalp cooling group were evaluable for hair loss. The authors stressed the need for further research on anthracycline-containing regimens, long-term hair loss measures and adverse effects.
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.