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Cooling caps to prevent chemothreapy-related hair loss are gaining popularity in the United States.
Using cooling caps to prevent chemotherapy-induced hair loss has been popular in Europe for decades, though it is now just starting to become popular in the U.S, according to Mikel Ross, BSN, RN, OCN. In December 2015, the Dignicap scalp cooling system from Dignitana gained FDA approval for use in patients with breast cancer.
“When you look at the first systemic reviews of data, the efficacy and the safety of scalp cooling, they go back as early as 1973,” Ross, office practice nurse at Memorial Sloan Kettering Cancer Center said. He went on to say that interest in scalp cooling in the United States has really only been shown in the last five years, with “clinical trials to gain acceptance and FDA approval of current cooling systems.”
Ross is optimistic about the future of the cooling cap. “Just as in the same way that we changed the landscape of the management of nausea and vomiting with new drugs, we're now going to change the landscape of this side effect with the implementation of scalp cooling.”
What scalp cooling systems have been used, other than Dignicap? How do the systems compare?
CURE sat down with Ross in New York City where he was presenting on the topic at the recent 34th Annual Chemotherapy Foundation Symposium™.Besides the Dignicap system itself, there's has been the traditional Penguin Cold Cap. We're certainly moving from the Penguin Cold Cap world, where we actually have to have caps that are cold that you switch off and on your head during therapy, to an actual continuous cooling system; the Dignicap is the first such system to gain FDA approval.
Can you identify any drawbacks of the cooling caps? How do patients tolerate the system?
What I can tell you is that while we have used the Penguin Cold Caps, we've had around 35 to 40 patients cooled, and in general, though we've not aggregated the data, we've had a number of success stories with patients keeping their hair during chemotherapy, with a variety of regimens. So we very much look forward to actually bringing the machines, which will simplify the process, into the infusion suite and really being able to address what I have heard called, “the last worst side effect of chemotherapy without a therapeutic intervention.”Tolerability is good, but it's not seamless. When you look at discontinuation rates in the literature, they range anywhere from 3 percent in the FDA trial of the Dignicap system, to as high as 12 percent in a Swiss cohort. So the things that patients will communicate is that certainly there's a cold sensation, certainly the cooling extends the amount of time they have to commit to their treatment, because there's pre-cooling, during the infusion cooling, and then post-cooling. So there's a convenience factor.
How broadly is the cooling cap being used in practice? Is it available to all practices who want to offer it?
By and large, especially for the patient who's very committed to the outcome of hair preservation, during-treatment tolerability is good and they move through the process and once again that is not the rate-limiting factor, in terms of their being able to use the intervention.At this time, scalp cooling is still very new and very limited within the United States. It's just now that we're able to communicate that not only can it work, but also that it's safe. And it's really been the safety that has limited the utility within the United States.
Is the scalp cooling expensive? Does insurance cover this system?
At present, there are no hard data, but I would say over 95 percent to 98 percent of patients do not even get this offered as an intervention at this time. As Dignitana has come to market, they've had a limited number of machines. Once again, there are limited centers which offer the machine. And of course, in those centers that do not, then the Penguin Cold Cap would be utilized for patients. But once again, it has yet to be fully embraced by both the nursing and the medical community, and it's only with the FDA approvals and these machines coming into the marketplace and coming into the treatment suite that we truly are changing practice patterns.At this time, private payers and third-party payers in general will not cover the expense of cooling. It can become quite expensive. Whether it’s the Penguin Cold Cap, which you rent the system for approximately $600/month and then depending on your length of treatment that can add up, or the Dignitana program which is contract-based with the institution, but there is a per-use charge, that accrues to the patient.
Will this system become part of routine practice?
Depending on the specific contract that exists between the institution and Dignitana, that cost to the patient can be variable. For some it's not much of a hurdle. But it is significant enough cost that the next step is to not let cost be the burden, but have advocates, providers, nurses, doctors, patients, go to the third-party payers and say this is a significant quality of life as well as physical outcome intervention, and it should be covered as part of the standard benefit package.I think five years from now, we'll consider it part of routine practice, the same way that we can see an IV-pump with an IV-pole as part of the regular equipment you would expect in an infusion suite.
How can oncology practices start the process of learning about the Dignicap?
It's going to be the trickle that becomes a waterfall, but we're not there yet. Hitting critical mass is the priority now. Once we do that, I do think you'll see a proliferation throughout treatment centers in the United States. And certainly one big aspect of that is the pending approval of an additional cooling system, the Paxman scalp cooling system, perhaps later this year by the FDA.For us, at Memorial Sloan Kettering, it's been a two-year journey: starting with the research into the literature to make sure that we were comfortable with not just the efficacy but also the safety—which has always been the long pole in the tent in terms of embracing this intervention.
What I would say is that, as these devices are approved, more clinical trial data exist. Reaching out to centers where they're actually implementing cooling, in order to find lessons learned, best practices, and how to actually integrate it into your treatment suite, that's what you need to be doing.