This headgear might prevent hair loss during undergoing cancer therapy.
Approximately 65% of individuals undergoing chemotherapy encounter hair loss as a side effect. This is due to the fact that the chemotherapy drugs target rapidly growing cells, yet they fail to selectively shield those that are not cancerous, such as those in hair follicles. In certain types of cancer, like breast cancer, hair loss occurs in 99.9% of chemotherapy patients.
Hair loss was determined to be the most distressing side effect of chemotherapy by 56% of patients in a 2019 study, and it can even cause some patients to reject treatment altogether.
One method to minimize hair loss is a technique known as scalp cooling, which involves wearing a headgear connected to a machine that circulates a cooling liquid through it. This reduces blood flow to the hair follicles and thus the quantity of drug they can absorb. In trials, around half of the patients who tried it retained 50% of their hair or more.
However, scalp cooling has its disadvantages. As Aaron Hannon, CEO and founder of Luminate, an Irish startup, points out, "The machines are large and physically fixed in place, which means patients are getting treated for hair loss before, during and after each chemotherapy session, spending two or three times as long in the hospital as they would otherwise."
Luminate has developed a portable helmet, called Lily, to improve upon current scalp cooling technology. This helmet allows patients to leave the hospital immediately after treatment, as they only need to wear it for 90 minutes following treatment.
The helmet uses gentle pressure rather than cooling, which means it doesn't need a pre-cooling period before treatment begins, making it faster. It also aims to improve patient comfort during treatment, as cooling therapy can be cold and somewhat painful for patients.
Luminate has conducted trials in Europe with promising results: About 75% of patients did not experience 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 good."
Hair loss significantly impacts patients, Hannon explains, not just their appearance but also their overall well-being and their ability to connect with others. "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 conduct clinical trials in the US and Europe next year, with a goal of launching commercially in the US first, once the technology has been approved by the US Food and Drug Administration. The cost to insurers is projected to be around $1,700 per helmet, while a course of scalp cooling treatment typically costs between $1,500 and $3,000.
The helmet works by applying gentle pressure to 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. This reduces the amount of chemotherapy agent that can reach the hair follicle and lessens its effectiveness.
Luminate, which employs a team of 35, began as a research project at the University of Galway in 2018, with Hanon leading a team of co-founders Barbara Oliveira and Martin O'Halloran, director of the university's Translational Medical Device Lab. It spun off in 2021 and recently raised $15 million in series A funding.
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 using scalp cooling for her patients for about eight years and currently uses an FDA-cleared technology that requires patients to wear a cap before starting treatment and then remain seated during the post-cooling phase.
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 for post-cooling patients.
They mention that scalp cooling can cause discomfort for certain individuals, but this doesn't guarantee that applying pressure will be altogether devoid of side effects like headaches. The intensity of the pressure used can influence patients differently. As per Luminate, the pressure felt is roughly a fraction, ranging from an eighth to a sixth, of the maximum sensation experienced on the arm during a blood pressure examination.
In Smith's opinion, avoiding hair loss is a significant advantage for cancer treatment. She explains, "Patients feel stigmatized by their cancer diagnosis due to the loud and clear signal that they're losing their hair and undergoing chemotherapy." Scalp cooling, she adds, offers a chance for patients to receive appropriate treatment for their disease while having a realistic prospect of retaining some, if not a substantial portion, of their hair.
Hannon adds that the initial results with the new pressure-based helmet show similar advantages.
For the patients who have benefited from our efforts, the impact has been immense," he said. "For some, this has transformed their entire experience with chemotherapy treatment, which is truly heartwarming."
The impact of hair loss on patients' well-being and self-esteem is significant, often leading to emotional distress and rejection of treatment. Applying gentle pressure to the scalp, as the Lily helmet does, could potentially reduce the number of chemotherapy patients experiencing hair loss, offering a significant improvement in their cancer treatment experience.
