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11-07-2017 | FDA | News

approvalsWatch

Chemotherapy cooling cap use expanded

medwireNews: A computer-controlled head cooling system may now be used to reduce alopecia in patients undergoing chemotherapy for solid tumors outside of the breast after the FDA approved expanded use of the system following evidence of safety and efficacy.

The DigniCap Cooling System (Dignitana Inc., USA) was granted marketing authorization in 2015 for women with breast cancer following a study of women with stage I–II disease that showed reduced hair loss in 66% of patients using the cap during chemotherapy.

However, the cap is not approved for pediatric patients and some groups of patients with specific cancers or chemotherapy regimens. Nor is the system suitable for patients at risk for cold-related injury.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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