SAN ANTONIO -- Use of a scalp-cooling device during chemotherapy reduced the incidence of severe hair loss by 50% in patients with breast cancer, according to a randomized study.

Half of the patients who used the electronic scalp cap had moderate or no hair loss, whereas all patients assigned to control therapy had severe or total hair loss. A subgroup analysis showed that patients treated with taxane-based chemotherapy, known to cause less severe hair loss, benefited the most from the cooling device. Nonetheless, a fifth of patients treated with more toxic anthracycline-based chemotherapy also had minor or no hair loss.

Relatively few patients had adverse events associated with use of the scalp-cooling device, the most common being headache, Julie Nangia, MD, of Baylor College of Medicine in Houston reported at the San Antonio Breast Cancer Symposium (SABCS).

Action Points Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Use of a scalp-cooling device during chemotherapy reduced the incidence of severe hair loss by 50% in patients with breast cancer.

Note that a subgroup analysis showed that patients treated with taxane-based chemotherapy, known to cause less severe hair loss, benefited the most from the cooling device and relatively few patients had adverse events associated with use of the scalp-cooling device.

"Scalp-cooling devices are highly effective for preventing hair loss in women receiving chemotherapy for breast cancer," said Nangia. "The manufacture of the device used in this trial is seeking FDA clearance to market it in the United States. Further studies are needed to explore this technology in patients with other types of tumors."

Scalp-cooling interventions have been around for years, but earlier interventions consisted primarily of wrapping the head with water-cooled fabric or other materials, which had little or no impact on hair loss, said Harold Burstein, MD, PhD, of Dana-Farber Cancer Institute in Boston. Results have improved dramatically with new-generation interventions, such as the one evaluated in the study that Nangia reported.

"I think the results are exciting," Burstein, who was not involved in the study, told MedPage Today. "It clearly prevents hair loss with some of the most common chemotherapy regimens we use in breast cancer. The improvement is not universal, and there are some regimens, particularly those containing anthracyclines, where it is not able to overcome the effects of chemotherapy. However, I think it's something people should be using more, and I hope there are approvals that will lead to insurance coverage and make this technology more widely available."

Even with the advent of targeted agents, chemotherapy remains a cornerstone of therapy for many patients with breast cancer. The therapy has played a major role in the improvement in survival for early breast cancer, but traditional chemotherapy carries well-recognized risks of adverse events.

One of the most distressing adverse events, particularly for women, is chemotherapy-induced alopecia, which occurs in a majority of patients treated with traditional chemotherapy. Although some agents are less likely to cause significant hair loss, such as taxanes, they are not alopecia free. Some patients with breast cancer find the hair loss so distressing that they may try to avoid potentially life-saving chemotherapy.

"Hair loss is really the last visible evidence of cancer...the hair loss identifies a person as a cancer patient, and many women find this very distressing," Burstein stated.

In recent years, several interventions have been developed to prevent or minimize chemotherapy-induced alopecia. In general, the devices are more widely available outside the U.S., primarily because of concerns that the devices might make cancer patients more susceptible to scalp metastases.

Both cancer cells and hair precursor cells divide rapidly, and chemotherapy targets rapidly dividing cells, making no distinction between cancer and normal cells. Cooling causes blood vessels in the scalp and hair follicles to constrict, reducing the rate of cell division but possibly creating the potential to trap circulating tumor cells that could coalesce into a metastasis.

Worldwide experience with the devices has increased to encompass several thousand patients without evidence of a metastasis risk. In 2015, the FDA cleared DigniCap for marketing in the U.S. Several others are in development, and Nangia reported findings from a randomized trial of the Orbis Paxman Hair Loss Prevention System.

As described during a press briefing at SABCS, the cooling device consists of a portable refrigeration unit attached to a cap that fits snugly to the head. Consistent contact between the cap and the scalp is required to achieve uniform cooling. Areas of the scalp that do not have direct contact with the cap do not achieve maximal cooling and have increased susceptibility to hair loss, said Kent Osborne, MD, also of Baylor, and a study co-author.

Investigators in the multicenter trial enrolled 235 patients with early breast cancer and planned adjuvant or neoadjuvant chemotherapy containing either a taxane or anthracycline drug. Subsequently, 182 of the patients were enrolled 2:1 to the scalp-cooling device or the control group. Patients assigned to the scalp cooler began treatment prior to the start of a chemotherapy session, and the cooling continued through the session and for 90 minutes afterward.

The primary endpoint was the proportion of patients who had grade 0 (none) or grade 1 (50%) hair loss as compared with grade 2 (>50%). The trial ended prematurely when a planned interim analysis showed a statistically significant advantage for the scalp-cooling device. The primary analysis included 95 patients treated with the scalp-cooling device and 47 in the control group.

The results showed that 50.5% of the patients assigned to the scalp cooler had grade 0 to 1 hair loss, whereas no patients in the control group had grade 0 to 1 hair loss. Analysis by type of chemotherapy received showed that 65.1% of patients treated with a taxane had grade 0 to 1 hair loss with the scalp-cooling device, compared with less than 21.9% of patients treated with anthracycline-based chemotherapy.

Acknowledging the impact of alopecia on patients' psychological status and self-image, Nangia said more studies are needed to examine the impact of chemotherapy-induced hair loss on those quality-of-life endpoints. She also called for development of specific quality-of-life measures to assess the effects of hair loss.

The study was funded by Paxman Cooling. Some co-authors were company employees. Nangia disclosed a relevant relationship with Paxman Cooling.