New FDA-Approved DigniCap Cooling Caps, Targets Side Effects

A medical device designed to help reduce hair loss and thinning caused by chemotherapy treatments has been approved by the FDA for use by cancer patients suffering from solid tumor cancers.

DigniCap Cooling System (“DigniCap”) is the first cooling cap approved by the FDA for cancer patients. It is a computer-controlled cooling cap worn by cancer patients during their chemotherapy treatments to help reduce hair loss and hair thinning typically caused by certain types of chemotherapy drug treatments and doses. The device circulates cooling liquid through the cap to the patient’s scalp and works by constricting blood vessels in the scalp, thereby slowing down cell division in the hair follicles and reducing the amount of chemotherapy drugs that reach those cells.

Although the DigniCap does not treat the cancer itself, its value is found in “managing the side effects of chemotherapy, a critical component to overall health and quality of life,” according to Dr. Binita Ashar, director of the FDA’s Division of Surgical Devices.

The FDA first allowed limited use of DigniCap in a 2015 marketing study of Stage I and Stage II breast cancer patients to determine the safety and effectiveness of the device. Of the 122 breast cancer patients evaluated during the study who had both chemotherapy and who used the DigniCap, 66% of those patients reported losing less than half of their hair.

Following this successful 2015 study, DigniCap won FDA approval for expanded use by all patients with solid cancer tumors after providing additional peer-reviewed scientific evidence of its safety and effectiveness.

Although many cancer patients have had positive results as it relates to reducing hair loss during their cancer treatment, the DigniCap is not successful with all chemotherapy patients and is not approved for use with pediatric cancer patients.

Short-term side effects are relatively minor including neck and shoulder pain, headaches caused by the cap’s coldness, and chills and pains caused by wearing the cap for long periods of time during chemotherapy treatments. There is also a rare risk of chemotherapy not reaching a cluster of cancer cells within the scalp. Long-term risks from scalp cooling or potential metastasis (spreading of cancer) in the scalp is not known at this time.