Scalp hypothermia as a preventative measure for chemotherapy-induced alopecia: a review of controlled clinical trials.

Chemotherapy-induced alopecia (CIA) is a temporary, yet psychologically devastating form of hair loss that affects 65% of patients receiving cancer chemotherapy. In the 1970s, scalp hypothermia was introduced as a preventative measure against the development of CIA. Numerous studies provide evidence for the effectiveness of scalp cooling to prevent CIA, although results varied because of differences in chemotherapy regimen, cooling technique, mode of administration and patient factors. However, many of the existing studies are uncontrolled or consist of small sample sizes, and data from randomized, randomized studies are limited. To date, no clear guidelines have been established for optimum scalp cooling use as a treatment modality and its efficacy remain unknown. Nonetheless, scalp cooling remains the most widely utilized method for the prevention of CIA, and in December 2015, the United States Food and Drug Administration (FDA) cleared the DigniCap Scalp Cooling System (Dignitana AB, Sweden) for marketing and the Orbis from Paxman Coolers Ltd. received clearance in 2017. This literature review is one of the first to provide up-to-date review and side-by-side comparisons of controlled and randomized clinical trials (CCTs and RCTs) evaluating scalp hypothermia for the prevention of CIA. Our analyses of CCTs and RCTs to date show that scalp hypothermia is effective in reducing the occurrence rate of CIA, by 2.7-fold in the CCTs and 3.9-fold in the RCTs. These results suggest that scalp hypothermia represents an effective preventative measure for CIA, and provide guidance for management of anticipated alopecia following chemotherapy and for future investigations.