Thanks to a new FDA clearance, cancer patients with solid tumors undergoing chemotherapy will now have the ability to have their scalp cooled by the DigniCap system to help prevent hair loss. Previously only indicated for breast cancer patients, the DigniCap Cooling System moves cool liquid through a cap worn by a patient during chemo sessions.
Cooling of the scalp narrows the blood vessels in the layers of tissue from which hair grows, which helps to keep the chemo agents out, and the colder temperature also slows down biochemical processes that participate in the chemo intake. The result is decreased hair loss, the amount of which of course depends on the patient and drug dosage delivered.
The FDA notes that pediatric patients, those with certain cancers, and certain chemo regimens are not advised to have the DigniCap prescribed to them.
Some notes from the FDA on how the expanded clearance came about:
In 2015, the FDA granted marketing authorization of the DigniCap for use in patients with breast cancer. For that authorization, the efficacy of the cooling system was studied in 122 Stage I and Stage II women with breast cancer who were undergoing chemotherapy, using recognized chemotherapy regimens that have been associated with hair loss. That study demonstrated that more than 66 percent of patients treated with the DigniCap reported losing less than half their hair. In support of the expanded use of the device, the manufacturer also submitted evidence from published, peer-reviewed articles that analyzed the application of the DigniCap to cancer patients with solid tumors in other areas of the body besides the breast. The FDA concluded that these studies provided valid scientific evidence to support the safety and efficacy of the expanded indication for the DigniCap.
The device is contraindicated for pediatric patients, patients with certain cancers and patient undergoing specific chemotherapy treatments. Additionally, DigniCap may not be appropriate for patients with cold sensitivity or susceptibility to cold-related injuries.
Product page: DigniCap…