New Scalp Cooling System Can Reduce Hair Loss From Chemotherapy: 2016 San Antonio Breast Cancer Symposium
Julie Nangia, M.D.
December 8, 2016

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Several studies have shown that cooling the scalp to a very low temperature can help reduce hair loss due to chemotherapy treatment for breast cancer. In this podcast, Julie Nangia, M.D., assistant professor of medicine, Baylor College of Medicine talks about the study results she presented at the 2016 San Antonio Breast Cancer Symposium on the Orbis Paxman Hair Loss Prevention System. The study was the first prospective, randomized trial on a scalp cooling system and found that about 50% of the women who used the cooling system kept most of their hair.

Listen to the podcast to hear Dr. Nangia explain:

  • how the Paxman Hair Loss Preservation System works
  • how the type of chemotherapy regimen the women were on affected the results
  • why doing a prospective, randomized trial was important

Running time: 9:54

Editor’s Note: On April 19, 2017, the Paxman Scalp Cooling System received U.S. Food and Drug Administration clearance. This means the system can be marketed in the United States.

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Jamie DePolo: This podcast is made possible by the generous support of Lilly Oncology. Welcome to the Breastcancer.org podcast. I’m Jamie DePolo, senior editor of Breastcancer.org. We’re down here in San Antonio at the 2016 San Antonio Breast Cancer Symposium. My guest is Dr. Julie Nangia. She’s assistant professor of medicine at the Baylor College of Medicine, and she just finished presenting research on the Orbis Paxman Hair Loss Prevention System and how it was safe and effective.

Julie Nangia: I’m happy to be here. Thank you for having me.

Jamie DePolo: Could you explain a little bit how the Orbis Paxman system works and how it’s maybe different or the same as some of the other systems that are out there right now?

Julie Nangia: Yeah. So, the way that scalp cooling in general works is that chemotherapy acts by killing rapidly dividing cells. So these are cancer cells, and hair follicle cells are examples of these. So, if you cool the scalp down — and the devices that we’re talking about cool that scalp down to about 64 degrees — then two things happen. One is that you can constrict, or narrow, the blood vessels in the skin of the scalp, and that prevents the chemotherapy from being delivered to the hair follicles and causing the damage that would result in hair loss. And the other way it works is that the coldness of the scalp can decrease the biochemical activity and the reactions that could cause hair loss. So those are the two ways in that scalp cooling work.

Until recently, the only scalp cooling that was available in the U.S. were the Penguin Cold Caps, and there’s some other companies that do that, but that’s the most common. And these are not devices, they’re basically very similar to ice packs. And they’re in the shape of a head, and they’re very labor intensive. Just like ice packs when you put them on, they’re very cold and they thaw out, so there’s different variations in temperature. And they have to be removed every 30 minutes and refitted.

So, scalp-cooling devices work a little bit differently in that this cap is attached to a refrigeration unit that circulates coolant, so that it only has to be fitted once. And the fit of the cap is very key, because if you don’t have proper pressure and fit of the cap, these don’t work. And so there’s two companies that do this. The one that was approved in the U.S. was in December of 2015, last year, and that was with a company called Dignitana that has the DigniCap. And the company that I’ve been working with is Paxman Coolers Ltd., and that’s the research we presented today.

Orbis Paxman Hair Loss Prevention System

Jamie DePolo: Okay. It sounds like this is almost like a reverse hair dryer. There’s a refrigeration unit that’s blowing cold air into the cap and the person wears it for the entire chemo infusion. Is that correct?

Julie Nangia: Yeah, not quite blowing, you know, it circulates it. So, there’s this inner cap, and the patient doesn’t feel air blowing or anything like that, it’s just a coldness. And the women that wear it kind of describe it like jumping in a pool, where it’s very cold for the first 15 minutes, but then you get used to it. And in our study, most women rated the device as being very reasonably comfortable. Now, there were some women who, after trying it or using it initially, stopped using it because they thought it was too cold or uncomfortable, but that was a very small amount of women. And then there were some women that because of other diseases should not use the device. The big one is a history of migraines because the coldness can aggravate migraines, and women with migraines just don’t tolerate the cooling.

Jamie DePolo: That makes sense. Now in the results, it said there was 50% success. Is that correct?

Julie Nangia: Correct. So in our analysis we looked at — this was an interim analysis, the trial stopped early because it was superior and very effective. So, there were 95 women in the group that had the scalp-cooling device, and 47 women in the control group who did not have the device. And in the control group, nobody had hair retention so it was a 0% success rate. And overall in the scalp-cooling group, 50.5% of women retained their hair, and we defined that as having less than 50% hair loss not requiring a wig.

Jamie DePolo: That’s pretty impressive. Did the results vary by the type of chemotherapy regimen that the women were on?

Julie Nangia: Yeah. So, there were definitely a lot of variations between different sites for many reasons. It’s known from many studies done in Europe and other countries that scalp cooling is more effective with certain types of chemotherapy. So in general, there are two main types of chemotherapy used for breast cancer treatment. And one is a taxane-based chemotherapy, and the other is an anthracycline-based chemotherapy. And the success rate with taxane-based chemotherapy is much higher. In our study we did an exploratory subgroup analysis of this, and there was a 65% hair retention rate with the taxane-based chemotherapy and a 22% rate with the anthracycline group. In the other company that has a scalp-cooling device in the U.S., there’s one other U.S. trial, they only looked at taxane-based chemotherapy, and their success rate was 66%, which is very similar to the 65% rate in our group. But they did use a different scale to grade alopecia, so you can’t directly compare the two groups.

Jamie DePolo: Were there any combination chemotherapies, like if somebody got an anthracycline and a taxane, and how did that kind of fall out as far as hair loss or hair preservation?

Julie Nangia: Yeah, so for breast cancer there’s only one chemotherapy regimen that uses anthracyclines and taxanes, it’s called TAC, and that’s not commonly used because it’s so toxic. But in other countries that has shown to not be effective to retain hair, and it was actually an exclusion criteria in our study. But most breast cancer chemotherapies do have other agents with them, and we used all the standard treatments that are used for early-stage breast cancer treatment. And our study was limited to stage I and II breast cancer because the FDA requested this.

Jamie DePolo: Now, I’m curious, if someone is interested in this cap, obviously it’s not approved yet, but would they…ultimately, would it be something that they rented or something that they purchased, or how does that work?

Julie Nangia: Yeah, so the Paxman Coolers, which is the group I work with, is applying for FDA clearance, and that process generally takes about 3 to 6 months. And from what I understand — you know I don’t work for the company — but from what I understand, at that point they are going to work with different hospitals and oncology clinics, and they will have these devices available in the hospitals and clinics that are interested in having this available for their patients. Initially, it would be self-pay because this is not a covered benefit through insurance. And the other U.S. company is charging between $1,500 to $3,000 per patient for the total treatment, to give you an idea of the price. I’m not sure what Paxman Coolers’ pricing will be because it’s not approved.

But long-term, I think my goal and Paxman’s goal is to lobby and try to get this as a covered benefit with insurance companies so that all women who want access to this can have access to this. In our trial, we actually, at Baylor, half my time is spent at a county hospital with underserved and underinsured, and this was available there as well as the Baylor Clinic in terms of research. And I would love that to be the case long-term, that no matter your income, just like with treatment, that you can get the same care. But unfortunately right now it is considered more cosmetic than medically necessary.

Jamie DePolo: And I know that this apparently is the first randomized trial on scalp-cooling systems, and can you tell us why that’s important?

Julie Nangia: Yeah, it kind of goes back to the insurance question you asked about. So, when we designed the trial, looking at quality of life was really important to me. And if you look across all the clinical trials with modern scalp cooling — so by that I mean devices not the caps — there really hasn’t been prospective randomized trials. So I thought it was important to have a scalp-cooling group and a control group, because we administered three different quality of life questionnaires. And these were given at baseline, after four cycles of chemo, which was our primary endpoint, and after completion of chemo if they were getting more than four cycles.

And unfortunately, our statistical analysis of these quality-of-life questionnaires did not show any difference between the scalp-cooling and the control group or that hair retention versus alopecia group, but the problem is there’s not really good quality-of-life tools to specifically assess alopecia alone. And a lot of these women’s quality of life has significantly affected just by a breast cancer diagnosis, surgery, going through chemotherapy. But my hope was that if we showed this it would help demonstrate that it was medically necessary to have access to this device, and I’m actually working with some other doctors and groups in other countries to develop a validated tool to assess alopecia, which may help with that approval process in the future.

Jamie DePolo: Thank you so much.

Julie Nangia: Thank you for having me.

Editor’s Note: On April 19, 2017, the Paxman Scalp Cooling System received U.S. Food and Drug Administration clearance. This means the system can be marketed in the United States.

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