The US Food and Drug Administration nods on the use of cooling caps on chemotherapy-induced hair loss (alopecia).
The patented cooling cap system developed by Swedish Dignitana was approved by the FDA for patients diagnosed with breast cancer patients only. Further, the cap is intended for those with solid tumors.
The decision is based on a clinical trial participated US women with early-stage breast cancer. More than 65% of them kept half of their hair. In another study, 117 women with either stage I or stage II breast cancer and had undergone at least four rounds of chemotherapy joined. More than 100 of these women wore a cooling cap during the study.
The researchers then compared photos taken before and after chemotherapy and analyzed the significance of the hair loss based on the Dean scale, wherein grade 0 meant no hair loss while grade 4 indicated over 75% of hair loss.
Upon comparison of the data, 93% of those who had not worn the cap scored a grade 4, much higher than the 15% of women with the cooling cap. More than 30% of the women with the cap were able to save as much as 50% of their hair.
The participants also didn't report any adverse side effects while wearing it.
The idea of using a cooling cap isn't entirely new. However, the process is more manual as the cap needs to be kept in dry ice or special coolers or freezers before it can be worn. Made from silicon, the Dignicap works by circulating cold temperature around the cap while the patient is receiving chemotherapy treatment. This way, the drug doesn't reach the scalp and weaken the follicles. The cap is connected to a unit that provides the coolant as well as monitors the temperature, making sure that it doesn't drop below freezing point. It can also adjust temperature according to that of the scalp.
The manufacturer hopes that with the FDA clearance, the cooling cap can help improve the quality of life of patients whose treatment can cause alopecia.