Breast cancer patients undergoing chemotherapy could soon have a new option to prevent hair loss: A special cap that cools the scalp during treatment. The Food and Drug Administration approved the device, known as DigniCap, on Tuesday.
Cooling contracts the blood vessels in the scalp, which reduces the amount of chemotherapy drugs carried to the hair follicles. The cap is marketed by Dignitana, a Swedish company, which says it’s the first scalp-cooling cap approved by the FDA .
Here’s what you need to know:
How well does it work?
In clinical trials, at least 66 percent of early-stage breast cancer patients who used the DigniCap lost less than half of their hair. All the patients who got chemo without the DigniCap, by contrast, lost more than half of their hair. An FDA spokesperson said the agency will post more data about the trial in a few days.
How much will it cost?
A course of treatment will likely cost $1,500 to $3,000; the total depends on how often the cap is used during chemotherapy, a Dignitana spokesperson said.
When will it be available?
We don’t know yet. The Dignitana spokesperson said the company is in negotiations with major hospitals about how to offer the DigniCap. She said the company hopes it will be available in weeks or months.
Are there any potential drawbacks?
Preventing chemotherapy from reaching the scalp could theoretically allow cancer cells to survive there. However, clinical trials have found a very small risk of this, according to Macmillan Cancer Support, a United Kingdom nonprofit.
Could it work for other cancers?
The device was tested in patients with breast cancer, and the FDA spokesperson said the agency can only approve its use for those patients, since that’s the only data available. Scalp cooling can’t be used for blood-based cancers such as myeloma, leukemia, or lymphoma, according to Macmillan Cancer Support, because there is a high risk that cancer cells in the scalp’s blood vessels could be shielded by the cold.