The DigniCap system prevented significant hair loss in 70.3% of the study patients. This new system is approved by the U.S. Food and Drug Administration (FDA). Ongoing studies continue to determine its efficacy and long-term effects.
Clinical Performance of the DigniCap System, a Scalp Hypothermia System, in Preventing Chemotherapy-Induced Alopecia
Authors: Rugo H, Klein P, Melin SA, et al.
Source: J Clin Oncol. 2015;33 (suppl):abstract 9518. .
The DigniCap system is a scalp-cooling device. It is FDA-approved to minimize alopecia during chemotherapy. This study followed 101 women with early-stage breast cancer receiving postoperative chemotherapy. Women receiving sequential anthracycline/taxane regimens were excluded. Subjects provided self-assessment of hair loss using photographs of their own heads. Seventy one patients had treatment success. Thirty-nine patients report minimal or no hair loss. Adverse effects included headaches, pruritus (skin irritation), skin pain, and head discomfort. These patients will be followed along for long-term safety.