For many women facing a breast cancer diagnosis, the thought of enduring the many side effects of chemotherapy—fatigue, infections from a weakened immune system, and loss of appetite, to name a few—is enough to make them question whether it is worth it. And then, of course, there's the prospect of losing one's hair, or alopecia, which is especially hard to take for many in this patient population.
Recognizing that the results varied in previous, non-randomized trials using scalp cooling devices to treat alopecia secondary to chemotherapy, a team of researchers led by Julie R. Nangia, MD, Assistant Professor of Medicine at Baylor College of Medicine in Houston, resolved to conduct the world's first randomized study to help provide more women access to scalp cooling technology.
In the aptly named Scalp Cooling Alopecia Prevention Trial (SCALP), 50.5 percent of patients responded to treatment, leading the researchers to conclude that using a scalp cooling device was “highly effective” in reducing and preventing alopecia secondary to chemotherapy (JAMA 2017;317(6):596-605).
Nangia, who is also Director of the Breast Cancer Prevention and High Risk Clinic at Baylor, said the results of the research confirm scalp cooling devices offer a safe and effective way to reduce and prevent alopecia, and to help bring an end to the devastating effects going bald has on a woman's body image and psyche.
“I decided to lead this trial because supportive care, and specifically hair retention, is very important to patients, and no randomized trials in the world were looking at this question,” Nangia told Oncology Times. A literature review by the researchers found some women have even described having chemotherapy-induced alopecia as being more difficult than a mastectomy.
Validation & Reward
Scalp cooling previously was only done in the U.S. with caps, and can quickly become expensive for infusion centers and patients because they must be changed frequently. By comparison, scalp cooling devices only need to be fitted on a patient once, in the infusion center.
The scalp cooling devices were not previously studied as a treatment for alopecia in the U.S. out of a concern about scalp metastasis, and despite being used safely in several other countries, according to the researchers. Two prospective trials in the U.S. have demonstrated significant hair retention rates in patients with breast cancer, however, leading the FDA to approve two different scalp cooling devices.
The SCALP “clinical trial validated the use of scalp cooling technology in the U.S.,” Nangia said. “Before this clinical trial, oncologists rarely discussed scalp cooling as an option for patients, even though scalp cooling with cold caps had been available for decades. Now, there is heightened awareness of what scalp cooling is, the risks and benefits of scalp cooling, and good data from a randomized, prospective clinical trial that physicians can use to understand the efficacy of scalp cooling.
“Current devices are much easier to use than caps, and major centers across the U.S. are adopting this technology as a service for patients, including Baylor College of Medicine, Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, and Cleveland Clinic,” she added. “It is also creating competition, so that centers who do not offer scalp cooling are seeing patients choose to be treated at centers that do.”
The SCALP clinical trial evaluated the safety and efficacy of the Orbis Paxman hair loss prevention system in reducing chemotherapy-induced alopecia.
The multicenter study was conducted at seven sites throughout the U.S. A total of 182 women with breast cancer requiring chemotherapy were randomized to scalp cooling (n=119) or control (n=63). Women with stage I and stage II breast cancer scheduled to receive anthracycline- or taxane-based chemotherapy for at least four cycles were eligible and randomized in a 2:1 ratio to scalp cooling or control. Scalp cooling was done with the device 30 minutes prior to, during, and 90 minutes after each chemotherapy.
Among women in the study with stage I and stage II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50 percent hair loss after the fourth chemotherapy cycle, compared with those who received no scalp cooling. The overall hair retention rate after completion of chemotherapy was 46.2 percent, and with taxane-based chemotherapy, it was 64.6 percent.
Scalp cooling was not as effective with anthracycline-based chemotherapy. The hair retention rate was 24.1 percent after four cycles of anthracycline-based chemotherapy, and 15.6 percent with sequential anthracycline and taxane treatment. Scalp cooling is also more effective with certain types of chemotherapy. For example, the hair retention rate was 100 percent with weekly paclitaxel.
“As a result of this clinical trial, the [Paxman] scalp cooling device received clearance by the FDA,” noted study co-author, Mothaffar Rimwari, MD, a medical oncologist at the Baylor College of Medicine. “These devices are now being used as standard of care in many infusion centers across the U.S. and becoming part of the standard of care for cancer patients.”
One big reason for that is the ability to inform clinical decision-making by oncologists, just as the study's authors predicted in this excerpt from the published study results:
“If scalp cooling becomes widely used in the U.S., decisions about type of chemotherapy may be informed by rates of hair retention with use of scalp cooling devices: for example, with ERBB2-positive breast cancer, a patient and physician weighing options for chemotherapy (docetaxel, carboplatin, and trastuzumab [TCH] for 6 cycles vs. doxorubicin and cyclophosphamide for 4 cycles followed by docetaxel and trastuzumab for 4 cycles [AC→TH]) may consider the fact that TCH chemotherapy has higher rates of hair preservation. Cost may also be used in decision-making about use of scalp cooling devices. Currently, scalp cooling devices in the U.S. cost about $1,500 to $3,000 total per patient and are not reimbursed by health insurance.”
Chuck Holt is a contributing writer.