FDA Approves Paxman Cooling Cap for Solid Tumors

The Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System — which reduces the likelihood of chemotherapy-related hair loss — for patients with solid tumors, such as ovarian, breast, colorectal and prostate cancers, according to a press release by Paxman, the United Kingdom-based manufacturer of the system.

Commonly known as a cooling cap, the Paxman Scalp Cooling System is a device that is placed on patients’ heads, similar to a hat, and uses cold temperatures to narrow the blood vessels in the scalp, reducing the amount of chemotherapy that reaches hair follicles. It was first approved for patients with breast cancer in April 2017.

“This is another step forward in making cancer therapy more personalized and putting the patients in the driver’s seat as we create more options and pathways as patients,” Debu Tripathy, M.D., professor of Medicine at The University of Texas MD Anderson Cancer Center in Houston and editor-in-chief of CURE magazine, said in a statement.

Over the past year, more than 200 Paxman Scalp Cooling Systems have been installed in the United States, with 65 more awaiting delivery and installation, according to the press release. By preventing or decreasing hair loss, the system helps improve quality of life for many of the patients who are burdened by chemotherapy-related hair loss.

“If you can take away the most feared side effect of chemotherapy, you’re changing a patient’s journey,” Nancy Marshall, founder of the Rapunzel Project said in a December interview with CURE.

Marshall’s organization works to spread awareness about the two cooling caps that are currently FDA-approved: The Paxman Scalp Cooling System and DigniCap.

“If you can go through your illness with a relative amount of looking normal, you maintain privacy,” she said. “If you have your privacy, you can choose who you want in the circle of people who know and people who support you.”

In the press release, Steven Isakoff, M.D., Ph.D., department of Hematology/Oncology and Medicine at Massachusetts General Hospital in Boston, echoed Marshall’s sentiment.

“Scalp cooling has been a real game changer for so many of our patients with breast cancer, minimizing the risk of one of the most dreaded side effects of chemotherapy,” he said. “Thanks to the recent expanded FDA indication for the Paxman Scalp Cooling system, so many more patients with solid tumors in the US can now consider this option as a safe and effective way to keep their hair during chemotherapy. We are already working on plans to make this available to all of our patients with solid tumors.”