JUL 08, 2017 3:00 PM PDT

Cooling Cap Device Scores Another Big Nod from FDA

WRITTEN BY: Xuan Pham

The cooling cap device that limits hair loss during chemotherapy just scored another thumbs up from the FDA. The regulatory body recently approved the expanded use of the cap for patients with solid cancers.

Dignicap \\ Image credit: Dignitana

“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” said Dr. Binita Ashar, director, Division of Surgical Devices, in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”

Traditional cancer treatment with chemotherapy involves using highly toxic drugs to kill errant cancer cells. Because the majority of these drugs do not discriminate between cancer and normal cells, patients experience collateral damages as adverse side effects. Hair loss (alopecia) is a common side effect of certain types of chemotherapy, typically associated with treatment for breast cancer. Though considered a temporary effect, minimizing hair loss is important to the quality of life for many patients.

Named DigniCap, the cooling system is manufactured by Dignitana in Sweden. It works by circulating a liquid coolant to a tight-fitting silicone cap worn on the head during chemotherapy sessions. A second cap made of neoprene covers this cooling cap to act as insulation and prevent loss of cooling. The entire system is computerized with sensors that continuously monitor scalp temperature and allow the system to maintain optimal cooling throughout treatment.

The coldness of the cap acts to constrict blood vessels in the scalp, reducing blood flow to the hair follicles and protecting the hair from the flow of toxic chemotherapy agents in the body. In addition, the cooling action slows down cell division activities of the hair follicles, which makes them less susceptible to the uptake of chemotherapy drugs. These factors together reduce the risk of hair loss associated with cancer treatment.

In 2015, the device was originally approved for breast cancer patients following the results of a study that showed the Dignicap minimized hair loss in 66 percent of breast cancer patients undergoing chemotherapy.

Of note, not all patients with solid cancers will qualify for the Dignicap. For example, the cap isn’t suitable for pediatric patients, those with cold sensitivities, or those with contraindicated cancers or treatments.

Nevertheless, the expanded access will help a larger group of patients by minimizing the psychological impact of the diagnosis and making the chemotherapy process more tolerable. Reducing hair loss during chemotherapy allows more patients to retain some normalcy and privacy in their lives.

 

About the Author
  • I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
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