All About Cold Caps
Dr. Hope Rugo is the lead researcher on a number of studies investigating new treatments for both early-stage and metastatic breast cancer. She was the lead researcher on the study that led to the U.S. Food and Drug Administration approval of the DigniCap, a cold cap that may help some women keep some or quite a bit of hair during chemotherapy.
Listen to the podcast to hear Dr. Rugo explain:
how she became interested in studying cold caps
how cold caps work
her research on the DigniCap
how much cold caps might cost and whether insurance is covering it yet
Affiliations: University of California San Francisco Helen Diller Family
Comprehensive Cancer Center, Translational Breast Cancer Research Consortium, Bioasis
Areas of specialization: medical oncology, hematology, breast cancer
Dr. Hope Rugo is a medical oncologist specializing in breast cancer research and treatment. A professor of medicine at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, Dr. Rugo is the director of the Breast Oncology Clinical Trials
— Last updated on May 2, 2022, 4:52 PM
Jamie DePolo: Hello, everyone, welcome to the Breastcancer.org podcast. My name’s Jamie DePolo, I’m the senior editor here at Breastcancer.org. And my guest today is Dr. Hope Rugo. She is a medical oncologist specializing in breast cancer research and treatment and a professor of medicine at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. Dr. Rugo directs breast oncology and clinical trial education, and is the lead researcher on a number of studies investigating new treatments for both early-stage and metastatic breast cancer.
Dr. Rugo is a member of the Breastcancer.org Professional Advisory Board, and she was also the lead researcher on the study that led to the U.S. Food and Drug Administration approval of the DigniCap, which is a cold cap that may help some women keep some or even quite a bit of their hair during chemotherapy. And this is what we’re going to be talking about today. So Dr. Rugo, welcome to the podcast. It’s a thrill to have you here. I know many of our visitors have said they are very interested in cold caps. So how did you get interested in studying cold caps?
Dr. Hope Rugo: Well, it’s an interesting story. When I was a medical student at the University of Pennsylvania, I had a patient I remember that was icing her head and everything; it didn’t work very well. And at the time we sort of poo-pooed the idea, and in fact thought that there might be a risk to using the cold caps, that you wouldn’t be getting chemotherapy to the scalp, and that that would be an issue. So I actually didn’t think about it again really until a patient came to me and said she really wanted to use cold caps. And I said, “Oh, they’re not available, and they don’t work,” and she said, “No, no, that’s not true.”
And so she brought me a bunch of literature. She’s a lawyer and had done quite a bit of work on it, and actually found Dignitana. It seemed an easier way to do cooling than using all these caps that had to be frozen with dry ice and changed every half an hour. So I actually, through this patient, contacted Dignitana and found out that they were interested in moving forward with FDA approval of the first scalp cooling device in the United States, and I started working with them then.
The patient herself used the Penguin caps that can be rented and then changed every half hour, and brought in her dry ice and everything. She remembers losing a fair bit of hair, but she kept more than 50% of her hair, and that allowed her to work without really telling people what was going on, which at the time was really important to her. So it really started at that point, and I said, “Oh, do you want to do this FDA approval? We’ll partner with you on it.”
And I jumped in there, and then we were able, through our program director Laura Etcherman, able to get funding through the Laszlo Tabar Foundation. And this foundation and one of the foundation’s directors have been very generous and very supportive of our goals, and so we were thrilled to be able to move forward with philanthropic support.
Jamie DePolo: That’s great. Now if you could explain, I know you sort of briefly mentioned there in your discussion about how the caps work, but basically it’s that chilling the head sort of keeps the chemotherapy medicine out of the hair follicles, is that right?
Dr. Hope Rugo: Well, probably there are at least two ways that this works, and some of it has been shown by really elegant work in electron micrographs, fancy pictures. One is that by cooling the scalp you actually quiet down the metabolism of the hair follicle and change the shape of the follicle cell. Therefore the cell may be less sensitive to the effects of chemotherapy, which kills rapidly dividing cells. So that’s one area, which is really a metabolic effect.
The second is the sort of classic thinking that you vasoconstrict, or you make the blood vessels sort of get narrower, and for that reason you deliver less blood and therefore less chemotherapy to the scalp.
Jamie DePolo: I see. Okay. Now I’ve read a couple places that some doctors have a concern about very small scalp metastases. In your study, was that an issue at all?
Dr. Hope Rugo: No, although we’re continuing long-term follow-up. There’s actually quite a bit of data on this now, and I think that the bottom line is that most of those physicians haven’t been keeping up with the available literature, and they sort of remember what they were trained, you know? And even that didn’t really have any literature behind it. You can’t go to studies that were done 30 years ago where one, the scalp cooling didn’t work well, and two, our treatment didn’t work as well as it does now. So there are a couple of those issues.
It turns out that scalp metastases as the first site of recurrence in breast cancer are exceedingly rare, occurring maybe 1% of the time. And if that’s the case, that they’re a really rare event and what you’re doing is increasing that, it’s easier to see the difference than a common event. I hope that makes sense. But it’s really that if you have something that’s very rare, and then you do an additional treatment and it increases that risk, a rare event is much easier to see increase than a very common event, because you don’t need very many to show that it’s more.
Jamie DePolo: I see.
Dr. Hope Rugo: And there’s been two large studies looking at patients who were treated with cooling caps that have seen the same overall survival, which is a really hard endpoint and easy to follow, and also haven’t shown an increase in reported scalp metastases as the first site of recurrence. And even in the patients who have scalp metastases, they have other sites of disease as well, suggesting that there’s no impact of scalp cooling on the incidence of scalp metastases.
And then lastly, we understand more about the way tumors grow and privileged sites, etc. And it’s very unlikely that tumor cells hang out in the scalp waiting to grow back someday. So this issue seems to be not really an issue, it was more a theoretical concern that we’ve disproven. And, in fact, the FDA was convinced when we went to them that this wasn’t a prominent concern. And we of course are still following our patients who were involved in both our pilot study as well as this trial that led to approval to make sure that we aren’t seeing any scalp metastases.
Jamie DePolo: Okay. And since we’re talking about your study, can you just briefly describe how many women were in it? I don’t know how you would do a placebo, or was it just different kind of cooling, or how did it work?
Dr. Hope Rugo: Talk about placebos to me is sort of ridiculous! [Laughing] I hate to say that, but it really is, because you get really cold, so how could you possibly use a placebo? And it seems unfair to make people sit with a cap on their heads that isn’t doing anything.
Jamie DePolo: True!
Dr. Hope Rugo: We talked about randomizing, and there is widespread availability of the Penguin Cold Caps, and a lot of our patients use them. Through the philanthropic support we also have freezer space for those cold caps. But of course you do need the person there to keep changing them every half hour, and you have to rent them externally. But because of that, if somebody really wanted to use cold caps, they are unlikely to allow themselves to be randomized.
So we talked about, because it’s so well known and well documented that these chemotherapy regimens cause complete alopecia, or hair loss, that we would have a non-randomized control, people who didn’t want to do scalp cooling, and we would follow those patients. The other thing I said is that if you randomize patients and they know they’re not getting scalp cooling, most women will shave their head after cycle two, so then you really have no control. The FDA thought that was a reasonable approach.
So what we did is, we had a control group, these non-randomized concurrently treated controls, so people are treated at the same time. And we said, “If we’ve enrolled 15 patients and none of them have kept any of their hair, then we should stop. If some of them have kept some hair, we’ll continue on.” And, in fact, we got to 16 patients, just because we have more patients enrolled, even, and none of those women kept any of their hair, they all had more than 50% hair loss. So that was very helpful in terms of our control population.
There are a couple of trials going on now that are attempting to randomize patients, not to sham or pretend cooling, but just no scalp cooling, and they’ve gone along slowly enrolling patients, so we’ll see if we’re able to get some useful information from that. I’m guessing it’s going to be quite difficult, but I think it’s a noble effort to try and do that type of study, I think mainly to look at patient-reported outcomes, more quality of life issues, etc.
Jamie DePolo: Now, you’ve mentioned… Oh, sorry, go on.
Dr. Hope Rugo: You asked about the number of patients, so I just thought I’d quickly answer that. A little over 100 patients. We did an initial 20-patient pilot study where everybody was treated, and this trial rejected over 100 patients receiving chemotherapy for early-stage breast cancer. They could not receive the most aggressive chemotherapy regimens that include both classic drugs called anthracyclines and taxanes.
They could get the taxanes though, and patients most commonly got a regimen referred to as TC, or docetaxel and cyclophosphamide. And we did it that way so that we could have less patients in the trial and get approval sooner. And then we knew that there were additional trials going on that are looking at that more intensive chemotherapy regimen, and there have been encouraging reports. So we’ll see that data, I think, in the next couple of years.
Jamie DePolo: Okay. Now you’ve mentioned a couple different kinds of caps, the DigniCap and the Penguin cap. And you sort of alluded to this, the Penguin caps you have to keep in the freezer, and you change them every half an hour while you’re getting the chemotherapy infusion. The DigniCap is different in that it’s actually attached to its own cooling system so you don’t change the cap, is that right?
Dr. Hope Rugo: Yeah, that is right. And the Penguin cap, it comes flat, and you form it to your head. And you have to keep it either in a freezer or on dry ice for 24 hours before you use them. And each cap, as it cools, you have to then put it back in the refrigerator, but it doesn’t get frozen again that day. So you need lots and lots of caps to get through your treatment. And the cap itself is colder, because it’s going to warm up, so it has to start colder. That’s the only other thing, also, it’s just a colder shock to your head each time.
The DigniCap and another system actually have a little machine, looks like a little mobile refrigeration unit, and that’s what it is. It has the coolant, and the cap looks like a bathing cap except for that it’s got channels inside where the coolant circulates, and then it has temperature sensors at the front and back of the cap so that it keeps it at a constant temperature. And what it does is, it continuously adjusts the temperature of the circulating coolant to keep it at this constant temperature. So basically you’re fitted with the cap and with an insulating cap over it, and then you leave that cap on during your chemo and for a period of time afterwards, and then you take it off.
Jamie DePolo: I see. And for all of them it sounds like you rent them, is that right?
Dr. Hope Rugo: For all of them you…?
Jamie DePolo: You rent them, you don’t buy them outright, you rent them from the company?
Dr. Hope Rugo: Well, so there’s not a “them.” For the Penguin cap you rent it from the company. For DigniCap, there’s not a them because you just have a cap put on your head and then it’s taken off. It’s attached to the machine, so you don’t actually go home with anything, you don’t bring anything in, and you don’t have to bring anyone in to help you, either. And so for that system there will be a fee per use that will be capped at a certain amount so that that’s all reasonable, and hopefully insurance companies will be more and more likely to pay part of that cost.
Jamie DePolo: Okay. So for the DigniCap it sounds like it would be up to the place where you’re getting your chemotherapy whether they had a unit or not, or would you contact the company and say, “I’m interested in this, can I get one shipped here?” or…
Dr. Hope Rugo: Right, well, the contract would have to be with the center where you’re getting your treatment. It would have to have a machine. And certainly I think patient encouragement helps with that, if there’s a lot of interest. And then the place will decide on its own sort of billing structure. So it could be that some places will be able to fund it on their own, or fund specific patients who can’t afford it, it’s hard to know. Other centers will charge a specific cost per visit, capped at a certain number in case you get multiple cycles of chemo. You couldn’t just keep paying every time, so it would be capped at some point.
Jamie DePolo: I see. I see, okay. Now you mentioned about the different types of chemotherapy, and I read this a couple of years ago, too, that different regimens produce different results with the cold caps. Did you see that in your research, or have you seen that in other research?
Dr. Hope Rugo: We have, it’s interesting. Some studies suggest that this anthracycline/taxane-type chemo, the more aggressive chemo for early-stage breast cancer, we know it’s more potent than the anthracyclines given in full dose, cause more hair loss. But sometimes it’s suggested that in a center which has a lot of experience and in these patients that you can keep at least 50% of the hair, and the patients are much happier. And if they keep about half their hair, then it fills in much more quickly than if you have no hair. So I think that certainly there are encouraging and positive publications out there.
There are also some that caution, and I think this is the case, that there’s more hair loss with that type of regimen than there is with the others. And so you have to be sanguine, or realistic, about that then, to know that you’re giving it a try and it may or may not work perfectly for you. And the whole idea of “perfectly” is important, because our endpoint was making sure that you had more than 50% of your hair at 1 month after the end of chemotherapy, because you won’t have any hair growth back yet at that time, that’s sort of the maximum hair loss.
But what that means is that people do lose some of their hair, and we advise that people not aggressively care for their hair during their period of chemotherapy. So wash their hair infrequently, don’t use products, use a non-sulfide gentle shampoo, things like that.
So for some women, they are not comfortable with that, because they want to maintain the more put-together look without wearing a wig or head covering, etc, and so what they’ll do is not do scalp cooling and wear a wig. But I pointed out to many of my patients that if they want to do the scalp cooling and keep their hair, and that they need to look a certain way for a certain event, they can still wear a wig.
Jamie DePolo: Oh, that’s true. That’s true.
Dr. Hope Rugo: But again, it’s not all the time. It just depends on what your sort of goals are and how you care for your hair, I think.
Jamie DePolo: And now are there any side effects to the cold caps?
Dr. Hope Rugo: Well, we’ve all had an ice cream and had that sort of between-our-eyes brain freeze. And that’s what some people have described, that as they’re doing the initial cooling in that first half-hour when you go from room temperature to cooling, which is a gradual process, that they’ll get a headache. Take a little light pain medication, headache gets better.
And then they stayed cold, and they don’t get more headache, which is interesting. But it is cold on the head. It doesn’t keep warming up and cooling down like the caps you take on and off, it stays cold. So once somebody’s adjusted they tend to tolerate it really well, and they drink warm tea and use a blanket.
Jamie DePolo: Okay. So the cold itself, I mean, obviously the headache, but the people being cold wasn’t really an issue?
Dr. Hope Rugo: I think one person in our trial went off because she didn’t like being cold. But that’s one out of over 100 patients, though.
Jamie DePolo: Right. That’s really good. Now I have only heard about this used in conjunction for women with breast cancer. Is this more widely used, or is this kind of the target audience? I mean, is it used by a lot of people with different types of cancer getting chemo? Have men used it?
Dr. Hope Rugo:v Yes, the answer to all of that is yes. It’s been used widely over in Europe and now in Asia, more recently, in patients who have a variety of cancers, and to some degree in men. It’s clear that men use it less frequently than women. And many of the chemotherapy regimens that are given for cancers that are more predominant in men don’t cause hair loss, either. But there are some men who have used it. So generally we like – first, you need to be receiving chemotherapy that causes hair loss, right? Some chemo doesn’t, but it’s very disease-specific. You want to get the best treatment for your cancer.
The second thing is that we don’t recommend using scalp cooling for so-called liquid cancers like leukemias, because those are cells that are everywhere at once. And also the treatment is so intensive that there’s no way that the scalp cooling would work. Similarly, we haven’t used scalp cooling in patients who are having bone marrow transplants, for example, who are receiving big, big doses of chemotherapy. But for other solid tumors, for example ovarian cancer and cancers that use chemotherapy that can cause hair loss, scalp cooling is a very reasonable option. And it has been tested around the world.
Jamie DePolo: Okay, okay. That all sounds great. And then my last question, I’m just curious, you mentioned this briefly earlier, too, but I wanted to kind of follow up. Is it covered by insurance at all yet? Do we know, if somebody were interested in this, should she talk to her insurance company? Is it likely that this is on their radar?
Dr. Hope Rugo: It probably is on their radar. I think that it’s very individual. We’ve had a couple of patients get partial reimbursement for scalp cooling, but that’s it. So it’s not on most insurers’ docket yet, but it’s being discussed, and hopefully there will be some reimbursement for it in the not-too-distant future. It’s very much dependent on your type of plan. Some plans don’t reimburse for anything, you know? So it depends on what kind of plan you have, and of course what the future holds for insurance deciding to cover it. But my guess is that we’ll see coverage, but it will be very much plan-dependent.
Jamie DePolo: Is there a range of what this might cost? Do we have any idea of that yet?
Dr. Hope Rugo: I think that it will be in the $2,000 or less per sort of the type of treatment you’re getting. That’s your whole treatment course, and that’s what you’ll spend, around $2,000.
Jamie DePolo: Okay. Okay. Well, Dr. Rugo, thank you so much. Is there anything else you want to tell us about scalp cooling?
Dr. Hope Rugo: I think really just that we’re now much more successful at treating breast cancer than we ever were before -- not always, which is why we’re all working on it -- and we really are in a position where understanding the impact on quality of life and really how long it takes to recover from treatment is critical. And one of the things that delays recovery is having no hair. I’ve had patients who just were extremely sensitive to the outward appearance, and it’s essentially a way for everybody to know what your business is without you telling them.
Some women really embrace hair loss. This is a very individual thing. So by no means are we suggesting that everybody should use scalp cooling. I think the issue is that we’re curing more women now than ever before with breast cancer, we want people to recover as soon as possible and suffer the least. So for women for whom hair loss is important, this is a very good thing that’s now available to the women in the United States, and we’re excited about that.
Jamie DePolo: That’s great. That is very exciting. Dr. Rugo, thank you so much. This has been a hugely informative podcast. I really appreciate your time.
Dr. Hope Rugo: Thank you so much for your interest and for these podcasts, which I think play a tremendous role and are a great service.