With the help of a scalp-cooling device, 50% of women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy were able to prevent hair loss, according to the results of the SCALP trial presented at the 2016 San Antonio Breast Cancer Symposium, held December 6–10 in San Antonio, Texas.

“Scalp cooling devices are highly effective and should become available to women with breast cancer receiving chemotherapy,” lead author Julie Rani Nangia, MD, assistant professor of medicine at the Lester and Sue Smith Breast Center, said during a press conference. “Further studies should be done exploring this technology for other types of tumors and with other chemotherapy regimens.”

The device, Orbis Paxman Hair Loss Prevention System, works by cooling the scalp, causing vasoconstriction and reducing blood flow to hair follicles during peak plasma concentrations of the chemotherapy drug.

This trial was the world’s first prospective, randomized trial of scalp-cooling. The trial included 235 women accrued from seven US sites. All women had stage I or II breast cancer and were planning to receive taxane and/or anthracycline-based chemotherapy. The women were randomly assigned 2:1 to receive scalp cooling or no cooling. For those assigned to scalp-cooling, the device was worn for 30 minutes prior to chemotherapy, during chemotherapy, and for 90 minutes after chemotherapy.

Alopecia assessments were made at baseline and 2 to 4 weeks after each chemotherapy cycle by a blinded healthcare provider, the clinician and the patient. Hair loss was assessed using the Common Terminology Criteria for Adverse Events Version 4.0, which defines grade 0 hair loss as no hair loss, grade 1 as up to 50% hair loss not requiring use of a wig, and grade 2 as more than 50% hair loss requiring the use of a wig.

Trial accrual was stopped early due to a positive superiority for the intervention seen at a planned interim analysis. Nangia presented the results of an interim analysis that included 95 patients in the cooling group and 47 patients in the no-cooling group.

More than one-half (50.5%) of patients assigned to cooling retained their hair compared with 0% of patients assigned to no cooling (P < .0001). Fifty-four adverse events occurred and all were grade 1 or 2. The most common adverse events were headache, nausea, and dizziness.

The researchers also assessed patient-reported comfort for those wearing the device on a scale from very uncomfortable to very comfortable.

“Most participants rated the device as reasonably comfortable and very few found the scalp cooling device to be uncomfortable,” Nangia said.

In addition, three quality of life questionnaires were administered at baseline, after 4 cycles of chemotherapy, and at completion of chemotherapy. Analysis of the questionnaires showed no difference between those assigned to cooling compared with no cooling or in the successful hair retention group compared with the alopecia group.

Finally, Nangia said that it is known that scalp-cooling devices are more effective in preventing hair loss with certain types of chemotherapy, such as taxanes. In this trial, the hair retention rate was 65% among patients taking taxanes and was 22% among patients taking anthracyclines.

According to Nangia, similar technologies have been used in Europe to prevent hair loss, but the technology has been slower to catch on in the United States because of concerns about cost and the potential for metastases to the scalp. Nangia and colleagues will follow the women on this trial for 5 years for safety and overall survival results.