Luminate helmet could help stop hair loss during cancer treatment

For cancer patients, the hair loss that may come with treatment can be hard to deal with.

An estimated 65% of people undergoing chemotherapy experience it as a side effect — because the drugs attack rapidly growing cells but can't selectively spare those that are not cancerous, such as in hair follicles. With some types of the disease, such as breast cancer, hair loss can occur in 99.9% of chemotherapy patients.

Although hair usually grows back within a few months of treatment ending, hair loss was deemed the worst side effect of chemotherapy by 56% of patients in a 2019 study, and it can even lead some to refuse treatment altogether.

One way to limit hair loss is a technique called scalp cooling, which involves the patient wearing headgear connected to a machine that runs a cooling liquid through it, to reduce blood flow to the hair follicles and therefore the amount of drug they can absorb. Their efficiency can vary, but in trials , about half of the patients who tried them retained 50% of their hair or more.

But scalp cooling has its drawbacks. "One is that the machines are large and physically anchored in place, which means patients are getting treated for hair loss before, during and after each chemo session, spending two or three times as long in the hospital as they would be otherwise," said Aaron Hannon, CEO and founder of Luminate, an Irish startup that is working on a helmet that aims to improve on current scalp cooling technology.

The helmet, called Lily, is completely portable, allowing patients to leave as soon as treatment is finished; Hannon says they will typically have to wear it for 90 minutes immediately after treatment.

It uses pressure rather than cooling, which means it doesn't need a pre-cooling period before treatment begins, meaning it works faster. It also aims to improve on another important factor, according to Hannon: "The comfort that patients experience during treatment," he said. "Cooling therapy is very cold and somewhat painful for patients to go through, so there's definitely been a lot of user feedback around trying to come up with a more comfortable alternative to the cooling devices."

Gentle pressure Luminate has been running trials in Europe with encouraging results: About 75% of patients did not have any hair loss, according to the company. "Patients on a very common regimen for breast cancer, for example, finished 12 cycles of treatment and kept almost all of their hair," Hannon said. "We haven't had any serious adverse events related to the device, so safety has been pretty good."

Hair loss has a significant impact on patients, Hannon says, not just on their appearance but on their overall well-being and their ability to relate to other people. "One of the things that encouraged us to even start this whole venture was just the experiences of patients," he said.

"I'll never forget speaking to a young mom who had breast cancer, and she was telling us how hair loss wasn't just important to her in the sense that we might think about, from an aesthetic point of view — she was saying that she just wanted her kids to think that she was OK and to not have to have the conversation with them that their mom was sick. But hair loss was the thing that forced that to happen."

Luminate aims to start clinical trials in the US and Europe next year, with a goal of launching commercially in the US first, once the technology has been cleared by the US Food and Drug Administration. Commercial launch would immediately follow, with the device being offered to patients through health insurance companies. The cost to insurers is projected to be around $1,700 per helmet; in comparison, a course of scalp cooling treatment typically costs between $1,500 and $3,000.

The helmet works by applying a small compressive force across the entire surface of the scalp, causing the tiny capillaries around the hair follicle to collapse. "As a result, the blood pressure inside those capillaries is exceeded by the pressure outside, reducing the flow of blood towards the hair follicle," Hannon said. This has two effects: Less of the chemotherapy agent can access the hair follicle, and there's less oxygen around due to reduced blood, which means any agent that still gets through is less reactive and less effective.

Luminate, which employs a team of 35, started in 2018 as a research project at the University of Galway, in Ireland, with Hannon working alongside co-founders Barbara Oliveira and Martin O'Halloran, who is director of the university's Translational Medical Device Lab. It spun off in 2021 and has recently raised $15 million in series A funding.

Changing the experience of chemo According to Andrea Smith, nurse leader at Memorial Sloan Kettering's Breast and Imaging Center, a cancer treatment center in New York City, the fear of hair loss affects treatment decisions.

"Patients in the past may have struggled to agree to a certain treatment if they knew that they were going to lose their hair," she said. "They may opt for something that's not as optimal, knowing that hair loss was going to be a real possibility, or they may delay their care."

Smith, who isn't involved with Luminate, has been working with scalp cooling for her patients for about eight years and is currently employing an FDA-cleared technology that uses caps connected to a floor unit. It requires pre-cooling, meaning patients have to wear the cap before starting treatment, and then have to remain seated for the post-cooling phase, which can vary in duration depending on the type of treatment.

A portable device, she says, would be a welcome improvement. "I think patients would like that," she said, adding that it would free up space in the center being taken by post-cooling patients.

She says that scalp cooling can be uncomfortable for some users, but that doesn't necessarily mean that using pressure will be completely free of side effects such as headaches, and the actual level of pressure used may affect patients differently. Luminate says that the pressure is comparable to a fraction — an eighth to a sixth — of the peak felt on the arm during a blood pressure test.

Whatever the method, avoiding hair loss is a "game-changer" for cancer treatment, Smith added. "Patients feel that people know that they have a diagnosis of cancer because they don't have any hair and must be going through chemo," she said. Scalp cooling "has given them the option to get the right treatment for their disease while having a real possibility of preserving some, if not a good portion, of their hair."

According to Hannon, the early results with the new pressure-based helmet show similar benefits.

"For those patients we've been able to have success with, the impact has been massive," he said. "For some, this has changed their whole experience of going through chemotherapy treatment, and that is really, really heartwarming."