Many cancer patients facing chemotherapy are aghast at the prospect of losing their hair, and for some years now in Europe and elsewhere there have been various scalp-cooling devices that promise to reduce this side effect.
Now the Food and Drug Administration (FDA) has cleared the first such device for marketing in the United States. The DigniCap Cooling System (manufactured by Dignitana Inc, in Lund, Sweden) has undergone a pivotal trial conducted at several centers in the US, and has been cleared for use to reduce hair loss in female breast cancer patients undergoing chemotherapy.
"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," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "Managing the side effects of chemotherapy is a critical component to overall health and recovery."
Hair loss is a big deal for many patients. "For many women, this is the most emotionally distressing and disturbing impact from their diagnosis," said Hope S. Rugo, MD, professor of medicine at University of California San Francisco School of Medicine and lead investigator on the DigniCap study. "A short course of chemotherapy results in total hair loss, taking many months to grow back," she told journalists earlier this year. Some women even think about skipping the chemotherapy "because it will adversely affect them at work when they lose their hair," she said.
DigniCap is a computer-controlled system that circulates cooled liquid to a cap worn on the head during chemotherapy treatment. The cooling cap is covered by a second cap made from neoprene, which fastens under the chin and holds the cooling cap in place. It also acts as an insulation cover to prevent loss of cooling, the agency explains.
The device is on show in the exhibition hall at the San Antonio Breast Cancer Symposium, which began today.
The cooling action is intended to constrict blood vessels in the scalp, which, in theory, reduces the amount of chemotherapy that reaches cells in the hair follicles. The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss, the agency explains.
The efficacy of the device was studied in 122 women with stage 1 and stage 2 breast cancer who were undergoing chemotherapy, using recognized chemotherapy regimens that have been associated with hair loss, the FDA notes. The data from this study may also be applied to some stage 3 and stage 4 breast cancer patients because they may have a benefit-risk profile comparable to that of the patients enrolled in this study.
The primary endpoint was a self-assessment of hair loss by the women using standardized photographs at 1 month (3 to 6 weeks) after the last chemotherapy cycle. More than two thirds (66%) of patients treated who wore the device reported losing less than half their hair.
Results from this study were reported earlier this year at the American Society of Clinical Oncology annual meeting.
Prevention of hair loss in these patients may be a significant benefit to their quality of life, and the risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare, the FDA notes.
The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time.
The FDA reviewed data for DigniCap cooling system through the de novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally marketed device.