Hair Preservation Improved by 50% with Investigational Scalp-Cooling Device
San Antonio, TX—The use of an investigational electronic scalp-cooling device in patients with breast cancer who had received alopecia-inducing chemotherapy resulted in reduced or no hair loss in 50% of the patients, according to results of a randomized clinical trial reported at the 2016 San Antonio Breast Cancer Symposium. By contrast, no patient in the control group had hair preservation.
Patients who received taxane-based chemotherapy, which is associated with reduced hair loss, benefited most from the use of a scalp-cooling device; however, many of the patients who received anthracycline regimens, which are associated with near-universal hair loss, also had reduced hair loss with the use of this device.
“Scalp-cooling devices are highly effective for preventing hair loss during chemotherapy for breast cancer. The manufacturer of this device is seeking FDA clearance to market the device in the United States. Further studies are needed to explore this technology in patients with other types of tumors,” said Julie R. Nangia, MD, Assistant Professor of Medicine, Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, TX. The results were recently published (Nangia J, et al. JAMA. 2017;317:596-605).
Scalp-cooling devices have been used for years outside of the United States to prevent chemotherapy-induced alopecia, with variable success. The FDA approved 1 device in 2015. However, until now, no randomized trials of scalp-cooling devices had been conducted. More studies are needed to determine the impact of chemotherapy-induced alopecia on patients’ psyche and body image, as well as the impact of alopecia-related instruments on quality of life.
The SCALP Clinical Trial
Dr Nangia reported findings from the randomized Scalp Cooling Alopecia Prevention (SCALP) clinical trial, which evaluated the Orbis Paxman Hair Loss Prevention System. The study included patients with early breast cancer who received a minimum of 4 cycles of alopecia-inducing chemotherapy (neoadjuvant or adjuvant).
A total of 182 patients were randomized in a 2:1 ratio to the Paxman device or to a control group that did not receive scalp-cooling treatment. Patients used the device starting 30 minutes before initiation of chemotherapy, continuing through chemotherapy administration, and for 90 minutes afterward.
The primary end point was hair preservation, defined as Common Terminology Criteria for Adverse Events grade 0 (no hair loss) or 1 (up to 50% loss, not requiring a wig). The trial had statistical power to detect a 20% absolute difference in hair preservation.
Patients self-reported the comfort level of the device and completed a battery of quality-of-life questionnaires.
The trial ended prematurely after a planned interim analysis of 142 randomized patients demonstrated a significant difference in hair preservation in favor of the group assigned to the scalp-cooling device. Approximately 66% of the patients received taxane-based chemotherapy, and the rest received anthracycline-based therapy.
Overall, 50.5% of patients using the scalp-cooling device met the criteria for hair preservation versus no patient in the control group (P <.0001). In a subgroup analysis, the cooling device resulted in hair preservation in 65.1% of patients who received taxane chemotherapy versus 21.9% with anthracycline-based chemotherapy.
The most common adverse event associated with use of the scalp-cooling device was headache (11.9%) during the first cycle of chemotherapy, declining to 10.7% during cycle 2, 1.5% in cycle 3, and 6.5% in cycle 4.
Approximately 50% of patients rated the scalp-cooling device as reasonably comfortable, and 12% to 17% of patients found it very comfortable, across the 4 cycles of chemotherapy. Another 25% to 30% rated the device as comfortable. The standard quality-of-life instruments used in the trial showed no significant differences between the 2 study groups.
Despite the trial’s relatively small size, the results added to “mounting evidence” that scalp-cooling devices warrant consideration for widespread use in the treatment of chemotherapy-induced alopecia, according to an accompanied editorial (West HJ. JAMA. 2017;317:590-599).
“Our patients, both women and men, are eager to avoid the visible stigma of cancer treatment in the form of sudden hair loss, an adverse effect that alters self-image profoundly,” Howard (Jack) West, MD, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA, wrote.
“While some may argue that we need long-term data on timing and patterns of recurrence as well as overall survival to ensure that there is no increased risk of scalp metastases or otherwise compromised outcomes for scalp cooling, there is no evidence thus far to suggest this. With the growing recognition of ‘patient-centered’ care and the recent FDA clearance for marketing one scalp cooling system, it is arguable that growing attention on interventions to reduce chemotherapy-induced alopecia is reaching an inflection point that justifies far more widespread adoption,” Dr West added.