Abstract P2-12-11: Use of the DigniCap™ System to Prevent Hair Loss in Women Receiving Chemotherapy (CTX) for Stage I Breast Cancer (BC)
Authors: Rugo HS , Serrurier KM , Melisko M , Glencer A , Hwang J , D'Agostino R , Hutchens S , Esserman LJ , Melin S 
Published: August 2014

Abstract
Background: Alopecia is a non-life threatening complication of adjuvant CTX for early stage BC. CTX induced hair loss affects quality of life and potentially impacts decisions regarding the risks and benefits of treatment. Scalp cooling (SC), used internationally by thousands of patients (pts) including a growing number in the U.S., is thought to prevent hair loss through decreased follicular metabolic rate and vasoconstriction resulting in reduced delivery and cellular uptake of drugs. The DigniCap™ System is a self-contained SC system with circulating coolant. We sought to evaluate feasibility and efficacy of the DigniCap™ System in pts with stage I BC.
Methods: We performed an initial prospective feasibility study before a planned pivotal trial. The primary endpoint was feasibility, defined as &lt;50% of pts discontinuing cap use due to cap-associated toxicity. Secondary endpoints included prevention of hair loss (HL) assessed by an independent panel (IP) consisting of a hairdresser, patient advocate, and dermatologist using photographs taken from 5 angles and blinded to pt and CTX cycle using the 5 point Dean's scale for HL: grade 0 (no HL), 1 (&lt; 25% HL), 2 (25–50% HL), 3 (50–75% HL), and 4 (&gt;75% HL). Pts assessed their own HL using the Dean's scale, and pt-assessed quality of life, time to and quality of hair re-growth, and impact of HL on treatment decisions were also evaluated. Successful prevention of alopecia was defined as &lt; grade 2 HL by the Dean's scale. Eligibility included stage I disease and excluded use of anthracycline-taxane combination or sequential CTX.
Results: 20 pts were enrolled. CTX regimens included: docetaxel and cyclophosphamide (TC) × 4–6 cycles (n = 16), weekly paclitaxel and trastuzumab × 12 (n = 2), and docetaxel, carboplatin, and trastuzumab (TCH) × 6 (n = 2). 19 of 20 pts (95%) completed all CTX using the DigniCap™ System. By IP assessment, 15 pts (75%) had a maximum of ≤ grade 2 HL; 2 pts (10%) and 3 pts (15%) had a maximum grade 3 or 4 HL respectively. By pt assessment, 11 pts (55%) reported ≤ grade 2 HL. 68% and 32% of pts reported grade 1 or 2 toxicity, respectively, including head/scalp pain, feeling chilled, and rash. 85% of pts reported that SC made decisions about CTX easier. At a median follow-up of 15.4 months, no scalp metastases have been observed.
Conclusions: Use of the DigniCap™ System is feasible, effective in preventing CTX-induced alopecia in the majority of users, and safe with short-term follow-up in pts with stage I BC. Additional studies should help to define potential causes for cap failure. This is the first prospective US trial to evaluate the effect of SC using an expert IP and blinded photographs to assess extent of alopecia. A larger trial is planned to confirm these results in pts with stage I/II disease.
Support for this trial was provided by the Tauber Foundation (UCSF), the Madonia and Cooper Funds (WFBH), and Dignitana.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-12-11.