Scalp Cooling Device Lowers Risk for Chemo-Related Hair Loss, Gives Patients Control

In an interview with Oncology Learning Network, Michelle Melisko, MD, Clinical Professor of Medicine, University of California San Francisco, and Melissa Bourestom, Vice President of Marketing, Dignitana (pictured: L-R), discussed the background, benefits, and future potential of the DigniCap Scalp Cooling System, which minimizes hair loss from certain chemotherapy treatments in patients with cancer.


Michelle Melisko, MD: My name is Michelle Melisko. I'm a clinical professor of medicine at the University of California, San Francisco. I specialize in the treatment of patients with breast cancer.

Melissa Bourestom: My name is Melissa Bourestom. I'm the Vice President of Marketing for Dignitana.

Dr Melisko: The DigniCap system is 1 of several scalp cooling device systems that have been developed to help prevent chemotherapy‑induced hair loss.

Chemotherapy‑induced hair loss has been one of the biggest obstacles to getting patients to accept or be willing to move forward with chemotherapy. It's one of the most dreaded complications of chemotherapy. Even though hair loss is most often reversible, it can severely impact patient's quality of life, both during chemotherapy and afterwards.

Having the option of providing some device, a scalp cooling device, that reduces or prevents some amount of chemotherapy‑induced alopecia has dramatically changed my ability to have a discussion with patients about the advantages or disadvantages of receiving adjuvant chemotherapy or neoadjuvant chemotherapy.

Ms Bourestom: In December of 2015, Dignitana received FDA clearance for the DigniCap Scalp Cooling System. That was based on the results of the pivotal trial, which was led by the researchers, including Dr. Melisko at UCSF and Dr. Hope Rugo.

That study found that 66.3% of patients were able to significantly reduce their hair loss during chemotherapy. That was considered to be a successful outcome for them to not have to wear some sort of head covering.

They were able to go about their daily lives without having to have that exposed to the world that they were undergoing chemotherapy treatment and had lost their hair, that kind of thing.

Dr Melisko: As I mentioned earlier, many patients making a decision about whether they're willing to accept chemotherapy in the first place have to weigh the risks and benefits to them.

Many times when we're offering patients adjuvant chemotherapy, we may be offering them a 3% to 5% reduction in risk of recurrence, which is a very hard number to put in someone's mind and say, "What does that really mean?"

The reality of losing their hair, which is essentially 100% of the time with most of the modern chemotherapy regimens is something that's very tangible to patients. Among all the side effects, even though alopecia is very reversible, most patients do grow their hair back. It is perhaps the most feared.

The opportunity to offer them this system that could at least give them the hope of preserving their hair has dramatic impact on that discussion. I would say that more patients are willing to consider chemotherapy if it's medically advised. They don't immediately run away from the conversation if they hear that there's a chance that they can preserve their hair.

I think what's also really even more remarkable is that even in the patients where we don't actually achieve success with scalp cooling, where they may eventually lose their hair halfway through the chemotherapy or 2/3 of the way through chemotherapy, or they get to a point where they don't like how their hair looks.

The fact that they have been able to get started with their treatment, maybe they have 2 or 3 rounds of chemotherapy under their belt where their anxiety is reduced, where their fear is reduced, then they're much more capable of coping with the idea of hair loss.

Even though a success rate, obviously, we would strive for a 100% success rate, the fact that we can preserve hair often early in the course of chemotherapy when patients are most anxious, most distressed is really important.

Ms Bourestom: We talk about 3 different factors when we work with patients with scalp cooling. Those would be privacy, identity, and control. Scalp cooling gives them the opportunity to maintain their privacy.

That's something that's very important to patients that you're walking down the street and everybody that you come across doesn't have to see you and instantly recognize that you look like a sick person. Being able to choose who you share your diagnosis with and when you do that is just a huge factor to so many patients.

The identity portion, of course, is really critical especially with women, but scalp cooling is something that's used with men and women and with any kind of solid tumor cancer. Just being able to look like yourself, to look in the mirror and see yourself. To not see a sick person looking back at you.

We all have that experience, even just when you have the flu. You look in the mirror and you say, "Ugh, I look terrible. I just need to get back into bed."

When you're going through your cancer journey, if you look better, then you're going to go and feel like getting up in the morning, eating well, exercising, and doing all of those things that you now are just feeling better about yourself in general. There certainly is a significant quality of life improvement there.

The third is an element of control, as Michelle was talking about, of really being able to choose that this is something that I'd like to try, that I get to make this decision.

For so much of cancer treatment, we really have to listen to what our doctors say and their extensive experience to say, "OK, well, if we're going to save your life, this is what we need to do." This is something that a patient can decide whether this is a priority for them. If they choose to do this to maintain their hair, then they get to make that choice.

Our goal as a company with Dignitana is to at least have this as a therapy that's available to any cancer patient in the country, and then let them make their choice.

We are in discussions about a couple different studies that I think we'll be starting in the first half of 2020. We'll have some more information on those coming out soon. One of them just looking at additional regimens, anthracyclines in particular.

Our initial pivotal trial just focused on taxanes. We want to look at the anthracyclines, ACT, those regimens.

Then we also are looking at expanding this therapy to a couple other patient populations. We'll have more details on that soon.

Dr Melisko: Another area that I think we still need to hone in a little bit is post cooling time that patients that go through chemotherapy, they finish, they then have to wear the cap for a certain number of minutes or hours after they finish up their chemotherapy. I think there is certainly work to be done still on optimizing that time.

We believe that for certain regimens, for example, for anthracyclines, that we might need to have patients wear the cap for longer. And then as it does roll out at other many, many places, many institutions, many private practices is figuring out how to manage the chair time and the space.

You know, cancer centers want to be able to offer this to their patients, but the infusion chair is a commodity where you have a lot of patients that many patients want to get in and be treated in the middle of the day. That's the optimal time.

We then have to figure out how to accommodate people's schedules, if they're sitting in the infusion chair for 2.5 hours versus 1 hour or something like that. I think that is another area moving forward to make it as feasible as possible across as many cancer infusion facilities as possible.

Ms Bourestom: One aspect of scalp cooling that we definitely are actively working on as a company to improveand have done so with the introduction of our new DigniCap Delta this yearis the reduction in nursing time that's necessary to administer the therapy.

We know that certainly chair time is a significant factor, but also making this device as easy as possible for the nurses to administer in what is most likely already a very busy infusion center setting.

And so making the cooling cap that they wear easy for them to fit, making sure that it fits all head shapes and sizes, really minimizing the amount of monitoring that the nurse has to do to check on scalp cooling and progress, making it so that the patients can disconnect themselves and easily go to the restroom, those are things that we've addressed with our new device, and that's made a huge difference to the nurses who are the ones that work with the patients very closely.

Another concern that is often addressed is the cost of scalp cooling. The current situation with that is that there is not a CPT code. There's not universal insurance coverage of scalp cooling therapy. However, we are pleased that many of our patients are receiving reimbursement, sometimes up to 100%, and that seems to be across all of the major providers.

Aetna, they have a statement that scalp cooling is medically necessary. A couple of the other providers have chimed in with similar statements. That's great but, of course, that doesn't necessarily mean that depending on your state and your plan that it will be covered for you, so we do work directly with our patients.

We have an extensive outreach program with our patients to encourage them to file for insurance reimbursement, give them all of those materials to submit to the insurance company. And then we also fund a couple foundations to help patients with financial hardships so that they're able to do that also. So we do certainly hope to make some progress on the insurance front in the next year or so.

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