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.”
CURE sat down with Ross in New York City where he was presenting on the topic at the recent 34th Annual Chemotherapy Foundation Symposium™.
What scalp cooling systems have been used, other than Dignicap? How do the systems compare?
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.
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.”
Can you identify any drawbacks of the cooling caps? How do patients tolerate the system?
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.
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.
How broadly is the cooling cap being used in practice? Is it available to all practices who want to offer it?
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.