The Dignitana DigniCap Cooling System, a computer-controlled device aimed to reduce the severity and frequency of hair loss in patients who receive neoadjuvant or adjuvant chemotherapy for breast cancer, has been cleared by the FDA as the first cooling cap for use in the United States.
“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” William Maisel, MD, acting director of the FDA’s Center for Devices and Radiological Health’s Office of Device Evaluation, said in a statement. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
The clearance is based on a multicenter, FDA-approved clinical trial examining the effects of the scalp hypothermia system in 122 women with stage I/II breast cancer who were undergoing alopecia-inducing chemotherapy. Results of the open-label, nonrandomized study showed that more than 66% of the women who used the device lost less than 50% of their hair.
The cooling cap, manufactured by Sweden-based Dignitana, circulates cold liquid through a silicone cap that is worn on the head during treatment with chemotherapy. The cap is connected to a unit that distributes the cooled liquid as well as a control unit with touchscreen prompts. A second cap made of neoprene holds the initial cap in place and prevents loss of cooling.
The near-freezing temperatures are intended to constrict the blood vessels in the scalp, making it difficult for toxic chemotherapy agents to reach and harm the hair follicles. The cold also decreases the activity of the hair roots, which slows down cell division and makes them less affected by chemotherapy.
“We are thrilled to be able to advance the science of hair preservation for women who must undergo chemotherapy and to find ways to make life saving treatments more tolerable,” said Laura Esserman, MD, professor of Surgery, director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center, in a statement. “An FDA approved product that makes scalp cooling available for women across the country is extremely good news.”
The trial’s primary endpoint was a self-assessment of hair loss. Patients photographed their hair 3 to 6 weeks after their last chemotherapy treatment, and provided a satisfaction score, ranked 0 to 100 with 100 being “completely satisfied.”
The mean satisfaction score with the decision to use scalp cooling was 87.5, the mean hair quantity score was 70.9, and a mean score of 69.1 was reported for hair quality.
No severe adverse events were reported. Most patients did report experiencing chills during the cooling down period; however, only 3 patients discontinued use for this reason. Other side effects included cold-induced headaches and neck and shoulder discomfort.
Eligible patients for the pivotal study were aged ≥18 years, had stage I/II disease, and had a planned course of neoadjuvant or adjuvant chemotherapy with regimens including doxorubicin, docetaxel, paclitaxel, and/or targeted agents, such as trastuzumab and lapatinib. Patients needed to be at least 2 years past their previous chemotherapy treatment that caused alopecia with complete recovery and had to have a Karnofsky performance status of ≥80%.
“Some of today’s most powerful, life-saving chemotherapy treatments still cause complete hair loss, a side effect that many women consider to be emotionally devastating,” lead investigator Hope S. Rugo, MD, director of Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center, said in a statement. “This FDA clearance means that for many cancer patients in the United States, chemo-induced hair loss will no longer be a distressing concern.”
Scalp cooling was mainly evaluated on regimens including taxanes, such as paclitaxel and docetaxel. Outside of the United States, the cap was also used with patients who received epirubicin and doxorubicin.
The study authors stated that these results suggest that scalp cooling could also apply to patients with stage III/IV breast cancer, as this subgroup may have a benefit-risk profile comparable to the patients enrolled in this study.
“I am profoundly grateful to be supporting a system that is able to minimize the psychological impact of an overwhelming diagnosis,” said Ingrid Tauber, PhD, clinical psychologist and president of the Laszlo Tauber Family Foundation, in a statement. “Scalp cooling offers patients a way to maintain their dignity, self-esteem, and sense of empowerment, offering an alternative to one of the most dreaded side effects of chemotherapy.”
Dignitana is currently finalizing agreements with US cancer institutions and community oncology groups for immediate DigniCap use.
“This FDA clearance means that, finally, breast cancer patients in the United States will have access to a convenient, safe, and scientifically proven option for reducing chemotherapy-induced hair loss,” Jan Richardson, CEO of Dignitana, said in a statement. “We are tremendously excited to be able to offer this state-of-the-art technology to hospitals and infusion centers across the United States.”
Efficacy and safety of Dignicap System for preventing chemotherapy induced alopecia. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT01831024. Accessed December 14, 2015.