Scalp-cooling devices gaining momentum in US, but more data needed

MIAMI — Significant advances have been made with scalp-cooling devices to reduce hair loss among women with breast cancer, and this has contributed to increased enthusiasm for these devices in the United States, according to a presenter at Miami Breast Cancer Conference.

“Temporary hair loss is one of the most distressing and traumatic side effects of chemotherapy,” Michelle Melisko, MD, clinical professor of medicine at UCSF Helen Diller Family Comprehensive Cancer Center, said during a presentation. “Women with chemotherapy-induced alopecia ... report low self-esteem, poorer body image and lower quality of life. In addition, hair loss impacts a patients decision to accept or decline chemotherapy. As many as 8% may decline chemotherapy due to risk for alopecia.”

Chemotherapy regimens associated with delayed hair growth or permanent alopecia include those that contain docetaxel. Hair loss is associated with dose and duration of therapy — incidence is less frequent at 75 mg/m² vs. 100 mg/m².

Strategies to reduce or prevent hair loss include scalp tourniquet, topical minoxidil and scalp cooling.

“The rationale for scalp cooling is vasoconstriction, which reduces the blood flow to hair follicles during peak plasma concentrations of chemotherapy that reduces the cellular uptake of chemotherapy,” Melisko said. “It also reduces biochemical activity, which makes hair follicles less susceptible to damage from chemotherapeutic agents.”

Melisko discussed several caveats and challenges with scalp-cooling devices.

“For one, past studies assessing the devices were generally small and poorly designed,” Melisko said. “There have also been considerable variations in success rates reported. Variables used to describe success were also inconsistent, and more data [are] needed on the length of cooling time and how cold it needs to be. There is still a lot of work to be done in this space.”

Two automated, freestanding devices have been cleared by FDA for use to prevent chemotherapy-induced alopecia. They are the DigniCap Cooling System (Dignitana) and Paxman Scalp Cooling System (Paxman).

“However, despite the significant advancements in scalp-cooling devices, they are still not covered by insurance,” Melisko said. “There have been delays in the United States due to concerns about increased risk for scalp [metastases] and poor efficacy. Advocacy is currently ongoing to get these devices covered by insurance as a standard supportive care measure. Until then, there are patient assistance programs to help with costs.”

More recently, there has been an increase in the number of prospective, well-designed trials assessing the safety and efficacy of scalp-cooling devices.

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A nonrandomized study of the DigniCap system included women with early-stage breast cancer receiving an anthracycline-containing adjuvant chemotherapy regimen. Results showed a 66.3% success rate in hair preservation with DigniCap vs. 0% among matched controls.

“It is important to note that efficacy is regimen, and likely user, dependent,” Melisko said. “In addition, optimization of required cooling times is still an open research question.”

Results of the Paxman SCALP trial showed women with early-stage breast cancer who underwent scalp cooling with the Paxman system were significantly more likely to have less than 50% hair loss after the fourth chemotherapy cycle than those who received no scalp cooling.

“The overall efficacy rate in this trial was slightly lower than the DigniCap study, which was probably largely driven by the chemotherapy regimens that were used,” Melisko said. “The efficacy rates were also highly variable based upon study site, which suggests there is a learning scale to using scalp-cooling devices.” – by Jennifer Southall

Reference:

Melisko M. Preventing chemotherapy-induced hair loss. Presented at: Miami Breast Cancer Conference; March 7-10, 2019; Miami.

Disclosure: Melisko reports no relevant financial disclosures.