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Clinical performance, efficacy, and safety of the DigniCap system, a scalp-hypothermia system, in preventing chemotherapy (CTX)-induced alopecia in patients (pts) with early-stage breast cancer (BC).
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Scalp cooling prevents chemotherapy-induced alopecia by reducing the amount of drug delivered to scalp cells and by decreasing intra-follicular metabolic rate. Several devices exist and are in use world-wide. The most common use a series of gel caps that are time-consuming and cumbersome to use. The DigniCap is a free-standing system that utilizes a circulating coolant in a silicon-based cap and maintains a stable scalp temperature. More than 3200 patients have used this system in Europe, Russia and Japan. The majority were treated for breast or ovarian cancer. Overall success rate assessed by wig use is about 85% and varies by CTX regimen (Dignitana data on file). A review of 2000 patients found minimal toxicity (Breed WP, 2004). Scalp metastases are rare (0.6% in 1593 pts in 6 studies). Improved sense of wellbeing (quality of life and body image) has been documented among pts using scalp cooling (Van den Hurk, 2009). This study is a pilot study intended to evaluate the safety and efficacy of the DigniCap system in pts with BC receiving standard CTX at 2 centers in the US. Methods: Pts with stage I BC receiving CTX with either a taxane or an anthracycline are eligible. Scalp cooling begins 30 minutes prior to CTX and continues for up to 90 minutes after CTX; scalp temperature is maintained at 5C. Photographs of the hair/ scalp are taken at baseline, at each CTX cycle, and at 3, 6, and 12 months after end of CTX and will be quantitatively graded by a panel of independent reviewers blinded to CTX cycle. Pts will also quantitatively assess their hair loss during CTX. Toxicity, quality of life, body image, and impact of hair loss on treatment decisions will be assessed at baseline, during treatment, and at follow-up visits. A 20-patient feasibility study is currently enrolling with plans for a 100-pt pivotal trial. The feasibility study will be considered successful if fewer than 50% of enrolled pts discontinue DigniCap usage due to associated toxicity. 4 pts have been enrolled to date; 3 are in treatment, and one is in follow-up. Funding is by the Laszlo N Tauber Family Foundation and by Dignitana.