FDA OKs Cooling Cap to Reduce Hair Loss from Chemotherapy

Written By:Stacy Simon
DigniCap Cooling System

The US Food and Drug Administration (FDA) has cleared for marketing a cooling cap to reduce hair loss in women being treated with chemotherapy for breast cancer. Hair loss is a common side effect of certain types of chemotherapy – including the types often used to treat breast cancer. Although hair typically grows back after treatment ends, it can take a long time. Reducing this side effect is considered important to overall treatment by improving quality of life for many women.

The first device cleared by the FDA is the DigniCap Cooling System, manufactured by the Swedish company Dignitana, Inc. It uses a computer to circulate a cooled liquid through a cap that a woman wears during chemotherapy treatment. A second cap made from neoprene covers the cooling cap in order to hold it in place and keep the cold from escaping. It’s thought to work by tightening up blood vessels in the scalp, which reduces the amount of chemo that reaches cells in the hair follicles. It’s also thought to decrease activity in the hair follicles, making them less likely to be affected by the chemo.

The FDA based its decision on a clinical trial of 122 women with stage I or stage II breast cancer who were undergoing chemotherapy. More than 2/3 of the women who used DigniCap reported losing less than half their hair. The most common side effects were headaches, neck and shoulder discomfort, chills, and pain.

Using cooling caps

Although the DigniCap is the first one to be cleared for marketing by the FDA, cooling caps (also known as cold caps) have been around for many years. Some devices can be rented or purchased online, and some cancer treatment facilities in the US allow patients to use them.

However, some doctors have been concerned that cold caps could interfere with chemo by keeping it from reaching any stray cancer cells lurking in the scalp. Some believe that the scalp cooling might protect any cancer cells there and allow them to survive the chemo and keep growing.

In its press release about the DigniCap, the FDA says, “The risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare.” However, the FDA did not provide information about whether studies have been conducted to measure long-term outcomes.

Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, says the decision whether to use a cold cap should be made by a woman with her cancer care team. “Women and their treatment team need to have discussions about whether this device is appropriate for them based on what we know and don’t know about their use, and applying their own personal values to make a decision.”

The FDA also has not commented about whether it will take any action on other devices similar to the DigniCap.

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