David Riseberg, MD, Medical Oncologist at Mercy Medical Center explains how the cooling cap works and how it helps patients.
Interview conducted by Ivanhoe Broadcast News in December 2018.
Tell me about the cooling cap, what is it and what is it designed to do?
Dr. Riseberg: We know that hair loss is common as a result of certain chemotherapy agents. And essentially it freezes the scalp and reduces the blood flow so that prevents the chemotherapy from getting to the hair follicles and can reduce the amount of hair loss.
When you say freezes could you give me some specifics, how, when does the patient put it on and how long do they have to wear it.
Dr. Riseberg: They do have to put it on beforehand. It adds time to the day, and sometimes these are long days to begin with. We have had some patients that said, well, I don’t think I really want to stick around that extra amount of time because it’s like thirty minutes or so before hand and at least thirty minutes afterwards, sometimes longer, sometimes it depends upon the type of hair and the medications being used. It cools the scalp and there’s some people who get a headache like a migraine headache. For people who have bad migraines, it is probably not the right thing for them. We did have someone recently who just couldn’t tolerate the coolness. But most people seem to tolerate it very well. That was an anomaly that we had with that one woman. People wear it and then the drugs are infused, then they wear it for little bit afterwards and then they take it off. And they have their own personal cap with the Paxman system. And as opposed to what we had done in the past at least a few women had done where they would bring these little caps that were in dry ice and they would change them out every 20 minutes. That was sort of a more rudimentary system still available. They put this cap on and there’s a coolant that’s hooked to a machine that’s infused and out to keep it continuously cool and they could just set in the chair.
And when you say cool, is there a precise temperature?
Dr. Riseberg: They’re in the sixties. You might want to look that up exactly.
Okay. Tell me about some of the chemotherapy agents.
Dr. Riseberg: The chemotherapy drugs that we use most frequently in breast cancer are: the taxeen drugs, which includes taxol and taxotere and a drug called Adriamycin and a drug called Cytoxan. And they generally all can produce hair loss, particularly the first two. We find that the hair follicle is among the cells in the body that’s dividing, that’s where we sometimes see the chemotherapy side effects. What we have found, though is that the Adriamycin seems kind of resistant to the cooling cap. At least in the clinical trials so we don’t encourage it there. Had some people do it but we haven’t had as much success. I do understand and other places have had some success with it, so it’s not like you can’t do it. But the taxanes, which again are very commonly used drugs, the success rate and the way they define success in the study was a woman being comfortable not wearing head covering in public. And it was around sixty or so percent success rate with the taxane base chemotherapy.
We’re talking breast cancer, so the majority of your patients will be women. What’s the benefit to using this cap?
Dr. Riseberg: Well, there’s so many devastating parts to a new diagnosis of cancer whether it’s breast cancer or another. Certainly with breast cancer there’s body altering surgery and a woman’s sense of body image is obviously going to be potentially permanently changed. There’s the big one of course, which is the concern about one’s survival and then there’s concern about feeling lousy as a result of the side effects. And although we’re better at treating many side effects, there’s still plenty of side effects. And then you put on top of that, oh well, you’re going to lose all your hair. And for most women that’s a huge downer. And that’s very devastating psychologically as well. So that if you can reduce that and get it to the point where it’s not zero hair loss that may be a more manageable amount of hair loss, it’s more like thinning. I mean that’s a huge plus. Certainly the women that have been successful, I mean they’re very pleased with it. And if that’s just one thing that they didn’t half to deal with I mean they’re dealing with so many different things, if you could take that off the plate that’s a good thing.
I wanted to ask you about the system itself. You had mentioned that earlier you had to change out a pack every thirty minutes. That’s not the case with the Paxman system. Can you walk me through on how that works?
Dr. Riseberg: That system is very labor-intensive, you really have to bring a cap buddy to do it because the nursing staff really just doesn’t have the time to do it. And people have to bring the cap to dry ice. With this system the cap is fitted in advance. The patient has a kit and they have a special shampoo that they use. And so they’re prepared. And they have the cap and, it just gets hooked up to this machine. And then it’s continuously running so there’s not really anything that the nurse has to do. The main thing that the nurse has to do it to make sure that the cap is fit snugly. That is really important for the success of the Paxman of the scalp cooling.
Does it get plugged into anything?
Dr. Riseberg: Just an outlet.
And what about the cooling system itself. Again, how does it get into the cap?
Dr. Riseberg: The coolant substance has to be changed very infrequently. So it’s not like it’s a water system where it has to be hooked to a sink or anything like that. It’s a self-contained unit. You just plug it into the outlet, you hook this tube up to the cap and you just turn it on and it does its thing. And the coolant goes through the cap and then it doesn’t require continuous maintenance by the nursing staff, cause nurses are busy. They are assessing patients, they’re obviously giving drugs, their monitoring the pumps, they’re monitoring for infusion reaction, cause they have to deal with this cap every twenty minutes, that’s going to be a no go. And that’s something that’s not required.
You had mentioned that this is now FDA approved for other cancers beyond breast cancer. Can you tell me what kind of cancers?
Dr. Riseberg: It’s really upon clinical trial data so initially the Paxman was approved in breast cancer because that was the population whom they studied, the cap. And they subsequently completed studies involving different varieties of solid tumors who have not achieved approval in the hematologic of blood malignancies, such as lymphoma, Hodgkin’s disease, leukemia, little concerned there because those are blood-borne illness that maybe there could be some detriment in freezing part of the body. But in general, it’s appropriate for all solid tumors which to me was not surprising, if it was going to work in breast cancer, it should work in the others. And really, the key thing is making sure that it’s a drug that is appropriate.
So again, not for blood-borne cancers, not for leukemia, not for ALL. Not for any of those.
Dr. Riseberg: Correct.
If you could tell me a little bit about Terri and her case?
Dr. Riseberg: We know she was diagnosed with breast cancer and testing indicated that chemotherapy was required, it’s fortunately, a situation where we’re done this as a precautionary measure to try to improve her chance for cure. But you she like many women, wasn’t excited about the idea of losing her hair and when we came up with the treatment plan it was one that did not include Adriamycin and so I felt she was a good candidate for it. And she was interested in. And again she had some thinning but it was not too bad. And I know that she’s been pleased with the results. It’s been certainly a good experience for her to have had this as something we could offer her.
Are there some of the eight other agents for the other kind of tumors where the cooling cap seems to work fairly well.
Dr. Riseberg: The taxanes are the drugs that we use a lot. Some chemotherapies don’t even cause hair loss that much. One thing would be not to use it in a situation where you’re not expecting a lot of hair loss anyway. It seems as though for a variety of different drugs and different diseases, they’ve achieved success. We’ve really been using it only in breast cancer so far just based upon the volume in the patients that have been interested but certainly many planning to expand beyond there. The key thing really is, is to not use it Adriamycin or similar drugs to that.
Could you spell Adriamycin?
Dr. Riseberg: A-d-r-i-a-m-y-c-i-n.
Is there anything I didn’t ask you doctor that you want people to know?
Dr. Riseberg: Cost. One downside is that currently this is not covered by insurance. Now, there are efforts underway to get coverage for it because it’s certainly something that treats the side effect that make sense but, it’s something that we really aren’t seeing consistently so far. There is a cost for the cap and there’s a cost per cycle. They do have a maximum amount that they will charge which is up to a few thousand dollars and then beyond that if a patient should unfortunately experience of recurrence and we were receiving an another chemotherapy drug for which hair loss is expected that cap is there as a make in and they can receive the cooling without any additional costs once they reach that total amount. But a few thousand dollars is a lot of money and a lot more to some people than others. There are some people for whom it’s a hardship. Now there are some things that we can offer to defray that costs both through taxane and some things that we have here and some other funds. But we can’t offer it for free. So that’s a potential downside. Hopefully we will see insurance coverage.
So the company does in some cases, you can apply to the company for funds.
Dr. Riseberg: The company does have a patient’s assistance fund. I have a couple other things.
Okay.
Dr. Riseberg: Paxman is one of a couple of systems that are available. We’re the first in Maryland to use Paxman. There is another one that is out there as well, which seems to work, similarly. There likely will be others down the road as we see this technology grow and be more readily adopted.
Dr. Riseberg: I’ve got one more thing.
Okay.
Dr. Riseberg: Well, two more things. One concern has been by cooling the scalp and preventing blood flow. You increase the potential of cancer returning in the scalp. That was the concern and this is the technology that was used with again, those were rudimentary caps thirty years ago and it was stopped because of concern about scalp metastases. But in the more recent studies they’re not finding that to be a concern. It’s no longer felt that scalp metastases should be considered of a concern and is not reason to you know, not offer this.
I think that’s all that I have.
Dr. Riseberg: Okay, sounds good.
END OF INTERVIEW
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