In oncology, sometimes we forget about the small, everyday things that can significantly impact a patient’s life. When patients are explained the side effects of chemotherapy and chemotherapy-induced alopecia, most women will cry or become visibly upset. When a woman loses her hair, it represents so much more—loss of anonymity/privacy, sexuality, and control. Some women will even choose to avoid lifesaving chemotherapy because they do not want to lose their hair. This stance has long been recognized, and the first attempts to prevent chemotherapy-induced alopecia through scalp cooling were introduced in the 1970s.
Some women will even choose to avoid lifesaving chemotherapy because they do not want to lose their hair.— Julie Nangia, MD
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Until recently, scalp cooling in the United States has been conducted with cold caps. Cold caps are not true devices and have to be changed out and refitted every 30 minutes. This process is very labor-intensive, requiring a dedicated person to help change out the caps. These caps also require a large cooler with dry ice (which takes up a lot of space in infusion centers) and have uncommonly been associated with cold-related injuries due to the very cold temperature when first put on. The caps can be ordered by patients and used anywhere if the infusion center allows them.
Scalp-cooling devices, however, are more convenient to use because the caps only need to be fitted once and a refrigeration unit maintains a constant temperature. To date, there have been no cold-related injuries reported with these devices. Unlike cold caps, scalp-cooling devices must be prescribed by physicians and are available only in infusion centers that lease them from vendors. They are not widely available in the United States at this time. Both the cold caps and scalp-cooling devices can be expensive ($1,500–$3,000) and are typically not covered by insurance.
Are These Devices Safe?
Scalp-cooling devices have been used in Europe and elsewhere since the 1990s, but they have not made their way into the United States until recently because of concerns about increased risk for scalp metastases. (The caps described here are not devices and are therefore not subject to the same U.S. Food and Drug Admininstration [FDA] regulations.) Data from other countries with large numbers of patients have shown these devices to be safe in patients with breast cancer, with no increased rate of scalp metastases or change in overall survival. As a result of these data, the FDA allowed the devices to be studied in the United States; two prospective trials were recently published in JAMA1,2 and are reviewed in this issue of The ASCO Post.
U.S. Scalp-Cooling Device Trials
The SCALP trial1 was the first randomized trial of scalp-cooling devices in the world; it showed a 50% hair retention rate in the group receiving scalp cooling and a 0% hair retention rate in the control group. The study included all types of chemotherapy commonly used in breast cancer, including anthracyclines, which historically have lower rates of hair retention with scalp cooling. As expected, there were higher rates of hair retention in the taxane-based chemotherapy group (65%) vs the anthracycline-based chemotherapy group (22%). These numbers were from the interim analysis, with a primary endpoint of four cycles of therapy. There were no significant grade 3 or 4 adverse events. There was no difference in quality of life between the group receiving scalp cooling and the control group. The final analysis was reported in a poster presentation at the 2017 ASCO Annual Meeting.3 The updated analysis showed a 53% hair retention rate in the scalp cooling group vs 0% in the control group after 4 cycles of chemotherapy. After completion of chemotherapy (4–8 cycles), participants with taxane-based chemotherapy had a 64.6% hair retention rate, and participants who received both taxane and anthracycline had a 15.6% hair retention rate.
The other prospective trial was a nonrandomized trial evaluating the effects of scalp-cooling devices in breast cancer patients receiving taxane-based chemotherapy.3 This trial showed a 66% rate of hair retention in the group receiving scalp cooling. In a descriptive analysis, there was an improvement in patients’ symptoms in the scalp-cooling group, with more patients feeling less physically attractive, less distressed by hair loss, and more satisfied with their body image.
As a result of these U.S. trials, there are two scalp-cooling devices that have been cleared by the FDA for use in all stages of breast cancer to prevent chemotherapy-induced alopecia. Many patients want access to these devices to possibly prevent chemotherapy-induced alopecia, but there are also still concerns by some about the risk for scalp metastasis. The amount of safety data from other countries is very reassuring, and there does not appear to be an increased risk of scalp metastasis in breast cancer patients using scalp-cooling devices. In addition, safety data will continue to be collected from the two U.S. clinical trials, and there are no safety concerns to date in either of these trials. It is important to note, again, that some women will decline lifesaving chemotherapy due to the risk of chemotherapy-induced alopecia. As a result of these findings with a scalp-cooling device, some of these women may now be more willing to undergo chemotherapy.
Another concern is the cost associated with the cold caps and scalp-cooling devices, which currently is unlikely to be covered by insurance. There are nonprofit organizations that can help patients cover the costs, so more patients may have access to this treatment. Researchers hope that after more data are collected on the impact of chemotherapy-induced alopecia on body image and psyche, scalp cooling will become a covered insurance benefit. Based on all of the data from studies in the United States and other countries, scalp cooling appears to be ready for prime time and hopefully will soon become more commonly used in the United States to prevent chemotherapy-induced alopecia. ■
DISCLOSURE: Dr. Nangia’s institution received support from Paxman Ltd for conduction of the clinical trial.
Dr. Nangia is Assistant Professor, Lester & Sue Smith Breast Center, Baylor College of Medicine, Houston.
1. Nangia J, Wang T, Osborne C, et al: Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: the SCALP randomized clinical trial. JAMA 317:596-605, 2017.
2. Rugo HS, Klein P, Melin SA, et al: Association between use of a scalp cooling device and alopecia after chemotherapy for breast cancer. JAMA 317:606-614, 2017.
3. Nangia JR, Wang T, Osborne CRC, et al: Scalp cooling Alopecia Prevention Trial (SCALP) for patients with early stage breast cancer. 2017 ASCO Annual Meeting. Poster 10088. Presented June 3, 2017.
An interim analysis of the SCALP trial, reported in JAMA by Julie Nangia, MD, of Baylor College of Medicine, and colleagues, showed that use of a scalp-cooling device significantly reduced hair loss in women receiving chemotherapy for stage I or II breast cancer compared with no scalp cooling.1 The ...