DR RUGO: So I’ve used the DigniCap, which is a self-contained system with 2 caps. And that, as you know, achieved FDA clearance last year in December. And we’ve just started up a clinical plan to use it. And so we have a number of patients using the DigniCap.

We’ve also used the Penguin Cold Caps a lot, which require, again, renting it — they all cost money. They all cost about the same amount of money. And then you need a freezer. So if you don’t have a freezer where you’re being treated, the patient has to bring in a cooler with dry ice. We happen to have freezers donated by a philanthropic supporter, and so our patients just need to coordinate the use of the freezer.

I will say that it involves personnel time. So you need to have funding for personnel who can either coordinate use of the freezer or coordinate use of the machines and the rooms in the infusion center so that you don’t have 3 people trying to use a machine that can have 2 people at the same time. And they have a postcooling time. And that’s something we’ve had to manage, because with the Penguin caps, you can get up and leave. You can go sit in the waiting room and do your postcooling.

But with the machines that are self-contained, you can’t leave as easily because the machine’s plugged into the wall. So these companies are working on having smaller machines that are more mobile. And they’re pretty small already, but where you might be able to actually take the machine along with you when you’re doing your postcooling, because you need to open up an infusion bed.

DR LOVE: You used the term “postcooling.” What is that?

DR RUGO: Yes. So after you get the cap on, you get the scalp cooler for about half an hour before you start the chemo. But then it takes a while — not the half-life of the drug, but actually just to get the biggest amount of circulating drug cleared. So depending on the drug, it could be an hour and a half, 2 hours or potentially even longer. We don’t know a lot about what’s required for postcooling time. It’s all done by anecdote. And we generally don’t go shorter than some period of time where you keep the scalp cool in order to allow the amount of drug in the system to go down.

I just want to mention one other system that’s being tested, called the Paxman system. Paxman is actually doing a randomized trial where patients are randomized to using the cap or not. And that trial is currently still accruing. And they don’t expect any results until at the earliest, next year. So that’ll be very interesting as well.

But we do have FDA clearance for a device ­— so we have the DigniCap and we have the Penguin cap now. So a lot of our patients actually do use scalp cooling.

DR LOVE: And what do they tell you in terms of discomfort, inconvenience and the whole experience?

DR RUGO: So it’s definitely cold, and it takes more time. And it takes some money. So those are the 3 biggest things. So I had one patient who said, “I hate to be cold. I’ve already decided I want to use the caps.” So that’s fine.

I’ve certainly had patients who couldn’t afford to use them. And actually, the people who helped us with coordination of the DigniCap trial is working with somebody in Texas on developing a philanthropic fund to help offset the cost for women who truly can’t afford to use the caps. So that’s one thing.

And the third thing is time. And so if you don’t want to spend the extra time and you don’t mind so much losing your hair, then that wouldn’t make sense for you. So those are really the 3 things that I think people find. Mostly people will take some lorazepam, a mild painkiller, for the beginning cold, because when it’s getting cold is when you have the most discomfort. The cap cools down and you feel like an ice freeze, like ice cream, bit on an ice cube or something, that kind of a discomfort. But it gets better, according to patients, quite quickly.

The one thing with the Penguin cap is it’s colder, and you change it every 30 minutes, so you keep getting colder each time as the cap warms up and cools down. But I have to say, the patients who’ve used it are very dedicated to it and, in general, are very happy with not losing all of their hair. Even if you lost, say, 55%, 45% of your hair, right? So you know your hair is going to look different for people who don’t have a mass of hair. You’re going to have more hair sooner, not because the hair grows any faster — we haven’t shown that — but if you already have half, the time it takes to fill in is less time. And I’ve seen that over and over again.

DR LOVE: What, globally, is the efficacy of these strategies? And do you even attempt to use it when a patient’s getting an anthracycline?

DR RUGO: We actually have had a number of patients use it with anthracyclines in our neoadjuvant setting. And mostly, it’s been Penguin cap, because the DigniCap wasn’t available. But now it is, so some people are using it. So we’ll see how it works.

Clearly, it’s harder to keep your hair during AC with the cooling caps, but patients still do. So maybe 40% keep their hair as opposed to closer to 70%. And keeping their hair is an individual thing. Your hair gets thinner. You lose hair, for sure.

Oh. One of the other reasons I forgot to mention why patients sometimes don’t want to use it is, you’re not supposed to wash your hair more than once a week and style it and color it and all that. And some of our patients said, “I’d rather wear a wig than look funny.” So it’s a very individual thing. But a lot of women are very, very sensitive to this. They want to keep their hair. They want it to be there faster. And they want to have some control over something in a situation where they have very little control.

DR LOVE: You see this mainly as a tool in the adjuvant and neoadjuvant setting or also with metastatic disease?

DR RUGO: We’ve used it, almost always, in the neoadjuvant and adjuvant setting, but I have a couple of patients in the metastatic setting who’ve used it, one of my patients who’s been on numerous lines of chemo and has never lost her hair. It was really important to her.

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