Julia R. Nangia, MD
Findings from the first prospective, randomized clinical trial to evaluate modern scalp-cooling demonstrate that the system is safe and effective in reducing hair loss in women being treated with chemotherapy for their breast cancer, especially for those on taxane-based regimens.
“The results of our interim analysis showed that in the scalp cooling group, 50% of participants retained their hair, and in the control group 0% did (P
<.0001),” reported Julia R. Nangia, MD, during a press conference at the 2016 San Antonio Breast Cancer Symposium. Nangia is an assistant professor of Medicine at the Lester and Sue Smith Breast Center at the Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine.
For this study, researchers evaluated the Orbis Paxman Hair Loss Prevention System (OPHLPS) in women being treated with neoadjuvant or adjuvant taxane and/or anthracycline–based chemotherapy for their stage I/II breast cancer. The multicenter trial was conducted at 7 sites across the United States, from December 2013 to September 2016.
Orbis Paxman Hair Loss Prevention System
The Orbis Paxman Hair Loss Prevention System, developed by Paxman Coolers Ltd, consists of a 2-cap system, with the inner silicon cap circulating a refrigerated fluid and the outer neoprene cap insulating the scalp and fitting snugly to the patient’s head with a chin strap. Both caps are fitted once and worn for the duration of each chemotherapy treatment. The 2-cap system ensures the coolant stays at a consistent temperature, and is connected to a small machine, which can be briefly detached from the patient to allow for greater mobility during sessions.
Participants (n = 182) were randomized in a 2:1 ratio to a scalp cooling or a control arm with no scalp cooling, and assessed for alopecia, quality of life (QOL), and safety. Patients were further stratified by treatment site and type of chemotherapy; they were not eligible for the trial if they had migraines, anemia, hypothyroidism, or other uncontrolled medical conditions.
Photo courtesy of Baylor College of Medicine
Those assigned to the scalp cooling arm wore the device for 30 minutes prior to their chemotherapy treatment, for the duration of their treatment, and for 90 minutes following treatment, Nangia explained. With most patients remaining 30 minutes in the clinic after chemotherapy, Nangia said scalp cooling means they have to stay about 1 hour longer.
Alopecia was assessed using CTCAE v.4.0 criteria: no hair loss (grade 0), hair loss of up to 50% of normal and no wig required (grade 1), and hair loss of >50% of normal, wig required (grade 2). Investigators defined success in preventing alopecia as grade 0 or 1. Alopecia assessments were conducted at baseline and at 2 to 4 weeks after each chemotherapy session by a blinded healthcare provider, the clinician, and the participant.
For those wearing the device, a comfort scale was also administered at each use, with responses ranging along a 5-point continuum from very comfortable to very uncomfortable. Three QOL questionnaires—the EORTC C30, the Hospital Anxiety Depression Scale, and the Body Image Scale—were administered at baseline, after 4 cycles of chemotherapy, and at completion of chemotherapy in women receiving >4 cycles.
Scalp Cooling More Effective With Taxane-Based Regimens
A total of 142 scalp cooling and control group participants (95 and 47, respectively) were evaluable at the time of the planned interim analysis in September 2016. The trial’s 50% success rate surpassed the trial’s superiority boundary, and as result, the Data Safety Monitoring Board agreed to terminate the study early.
Hair retention was better among patients on taxane chemotherapy, which was expected said Nangia, noting that the hair retention rate with taxanes was 65% versus 22% with anthracyclines.
The most common reasons that randomized patients dropped out were that they changed their mind or they were randomized to the control arm and wanted to use the cold cap. Four patients dropped out during the pre-cooling phase because the device was too cold or uncomfortable, and 1 felt claustrophobic; 1 other participant withdrew during chemotherapy, also because the device was too cold.
A total of 54 grade 1/2 adverse events (AEs) occurred, and the most common reported during cycle 1 were headache (11.9%), nausea (4%), and dizziness (3%). There were 8 unanticipated AEs, which included dry skin and scalp pain.
“Most patients rated the device as ‘reasonably comfortable’, and very few found it to be uncomfortable,” Nangia said. Responses to the QOL assessments showed no significant difference between the experimental versus control arm or in the successful hair retention versus alopecia group. “We’re still looking to develop a [tailored] alopecia-specific quality-of-life tool,” said Nangia, “one that may help scalp cooling to become a covered health insurance benefit, so that all women would have access to it.”
Scalp Cooling: Patient Education
Nangia mentioned that the study’s main limitation was variability in how well the device was fitted to patients’ scalps. “The fit of the cap is key,” stressed Nangia. “If there are any gaps, patients do experience hair loss.” As the trial went on, however, she said that nurses or other staff members became more skilled with using the device, increasing its effectiveness. She also cautioned that most patients will experience some thinning of their hair.
Between chemotherapy sessions, it is recommended that patients use sulfate-free shampoos because they are gentler on the hair and plenty of conditioner, as well as avoid products like straighteners that tug at the roots.
Women in this study will be followed for the next 5 years to monitor overall survival, recurrence of cancer, and potential metastasis to the scalp. Previously-reported mature data from very large studies (>1000 participants) of scalp-cooling systems in Europe where they are more widely used found no increased risk of scalp metastasis as the single site of recurrence or any decrease in overall survival between women who received scalp cooling and those who did not, Nangia noted.
Researchers on the study recommend more studies of this technology for other solid tumors and with other chemotherapy regimens, as well as additional research on the impact of chemotherapy-induced alopecia on patient psyche and body image.
Following on these trial results, the manufacturer intends to seek FDA approval for OPHLPS. The agency gave clearance to the DigniCap scalp-cooling system in December 2015.
Nangia J, Wang T, Niravath P, et al. Scalp cooling alopecia prevention trial (SCALP) for patients with early-stage breast cancer. Presented at: 2016 San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, TX. Abstract S5-02.