Among patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy, those who underwent scalp cooling were significantly less likely to experience chemotherapy-induced hair loss than those who did not receive scalp cooling, a study published in JAMA has shown.1
Although scalp cooling devices have been used to prevent alopecia caused by chemotherapy, its efficacy has not been established in a randomized clinical trial. Therefore, researchers sought to evaluate the efficacy and safety of scalp cooling compared with no treatment in women with breast cancer undergoing chemotherapy.
For the multicenter study (ClinicalTrials.gov Identifier: NCT01986140), investigators enrolled 182 patients receiving neoadjuvant or adjuvant chemotherapy with a taxane, anthracycline, or both, at 7 sites in the United States and randomly assigned them 2:1 to undergo scalp cooling with Orbis Paxman Hair Loss Prevention System or control. Their average age was approximately 53 years and 36% and 64% received anthracycline-based and taxane-based chemotherapy, respectively.
The interim analysis showed that 50.5% (95% CI, 40.7-60.4) of the 95 evaluable women in the scalp cooling experienced successful hair preservation, defined as no hair loss or less than 50% hair loss without requiring a wig at the end of 4 cycles of chemotherapy, compared with 0% (95% CI, 0-7.6). The investigators stopped the trial early due to scalp cooling being superior to no treatment (P =.0061).
Notably, there were no statistically significant differences in changes in quality of life from baseline to cycle 4 of chemotherapy between the 2 groups.
Investigators observed 54 adverse events in the cooling group. All were grade 1 to 2 toxicities. There were no serious adverse device events.
The findings suggest that scalp cooling is more likely to prevent chemotherapy-induced alopecia in patients with breast cancer than no treatment; however, further research is necessary to evaluate its long-term efficacy and safety.
1. Nangia J, Wang T, Osborne C, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer. JAMA. 2017;317(6):596-605.