Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Clears Expanded Use of Cooling Cap System
FDA news release; 2017 Jul 3
The FDA has cleared the expanded use of the DigniCap Scalp Cooling System to reduce hair loss during chemotherapy. This is the first cooling cap approved for use in cancer patients with solid tumors.
Indications: The system is indicated to reduce the likelihood of chemotherapy-induced alopecia.
Efficacy and safety: Original approval was based on a study that showed two-thirds of patients with breast cancer who used the system lost less than half their hair. Expanded use was based on results in patients with solid tumors in 1 of 3 additional body sites.
Side effects/risks: The most common adverse reactions are cold-induced headaches, neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time.
FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy. [news release]. Silver Spring, MD: FDA. July 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed July 14, 2017.