Adelaide, Australia—As a result of the FDA approval of the DigniCap (Dignitana) system last year, and the growing evidence that scalp cooling is effective in preventing chemotherapy-induced alopecia, the practice is steadily becoming more widespread in the United States. Hope S. Rugo, MD, Director, Breast Oncology Clinical Trials Program, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, is leading the charge on educating patients and providers on cooling options.
According to Dr Rugo, who spoke at the 2016 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology annual meeting, scalp cooling has historically not been available in the United States, despite substantial patient interest.
“Even though huge data sets were available, there was concern that this wasn’t an effective method of preventing hair loss. There was also concern over the potential risk of increased scalp metastases and thermal injury from scalp cooling, but the data have fairly definitively shown that there is no increased risk,” she said.
The Penguin Cold Cap versus Freestanding Systems
Penguin Cold Caps are patented, insulated gel caps that must be cooled in a freezer or on dry ice to –35oC before use. Because patients can rent the caps themselves and use their own cooler or special freezer (ie, medical centers do not have to provide them or play a role in their use), these caps have been the most frequently used scalp cooling device in the United States until very recently.
However, because helpers must be present for the duration of treatment to change the caps every 20 to 30 minutes, and the number of cold caps required is dependent on the type and duration of chemotherapy administration, following the recommendations exactly can be costly.
DigniCap, a self-contained system that circulates coolant through a tight-fitting silicone cap with temperature sensors connected to the cooling and control unit, was granted FDA approval in December 2015 based on the results of a pivotal trial led by Dr Rugo.
“Our challenge was convincing the FDA of the importance of preventing hair loss, so we pointed out the fact that many thousands of women have used the Penguin Cold Cap. They were also worried [that the study] wasn’t feasible, but we were able to demonstrate excellent feasibility and efficacy,” she said.
The researchers found the system to be very effective in reducing chemotherapy-induced alopecia, with clinically meaningful benefit. In the study, 66.3% of patients with breast cancer receiving neoadjuvant chemotherapy who used the DigniCap lost <50% of their hair compared with the control group (patients who opted out of scalp cooling entirely), all of whom had significant hair loss; the treatment was also safe and well-tolerated. The mean follow-up is now close to 2.5 years, with plans to continue, and no scalp metastases have been observed in the treatment group.
The Orbis Paxman Scalp Cooling System is similar to the DigniCap system, and is currently being tested in a US randomized trial that will provide eagerly awaited safety data.
“We hope this trial will lead to FDA clearance of the Paxman machine as well, but what’s important about this trial is, it will provide some crucial safety data that will be unequaled in a prospective trial,” said Dr Rugo.
The Future of Scalp Cooling
In the short-term, patients sometimes complain about a cold sensation, “brain freeze,” or headache from scalp cooling. Dr Rugo said she has seen occasional dermatitis and skin thermal injury, but only with the use of Penguin Cold Caps, which require strict temperature regulation. The main concern in the long-term has been the increased risk for scalp metastases, but she reiterated that “numerous studies in scalp-cooled patients suggest no difference in risk.”
According to Dr Rugo, patients and oncology providers should be better informed about scalp-cooling options. Improvements in scalp-cooling technology are crucial, as are the coordination of access and postcooling time issues, or “chair time.”
In the United States, where out-of-pocket costs can create barriers to care, organizations like HairToStay offer financial support to patients to offset the cost of scalp-cooling treatment for those who fall below the poverty line.
Dr Rugo and colleagues have spent considerable time and effort to cap the cost of the DigniCap system. “We don’t want scalp cooling to only be an option for people who have money and access,” she said.