Registry study to assess hair loss prevention with the Penguin Cold Cap in breast cancer patients receiving chemotherapy.

PURPOSE: Chemotherapy-induced alopecia is a distressing side effect of cancer treatment. The aim of this registry study was to assess efficacy and tolerability of scalp hypothermia using Penguin Cold Caps (Penguin) in breast cancer patients.

METHODS: Hair loss was assessed by patients using a 100-point Visual Analog Scale (VAS) and by physicians using the 5-point Dean Scale at baseline, every 3-4 weeks during chemotherapy, and at least 1 month after completion of chemotherapy. The primary efficacy endpoint for success was defined as ≤50% hair loss by patient report (VAS) at follow-up (FUP). Tolerability and satisfaction were assessed by patient report.

RESULTS: 103 patients enrolled between 7/2010 and 6/2015; 97 are evaluable for the primary endpoint. Chemotherapy included docetaxel/cyclophosphamide (TC; n = 50) for 4-6 cycles every 3 weeks, weekly paclitaxel for 12 weeks then doxorubicin/cyclophosphamide (P/AC; n = 23) for 4 cycles every 2-3 weeks, AC then paclitaxel (AC/P; n = 10), docetaxel/carboplatin ± trastuzumab (TCH; n = 4) for 4-6 cycles every 3 weeks. Overall, 61% of patients successfully prevented CIA; impact was regimen specific: TCH 100%, TC × 4 84%, TC × 5-6 50%, P/AC 43%, AC/P 20%. The most common toxicity was headache, reported by 78.5% of patients with mean pain level 37/100. Satisfaction among those who completed scalp cooling (SC) and FUP ranged from 74 to 100%. All patients who completed SC/FUP recommended Penguin.

CONCLUSIONS: Scalp hypothermia with Penguin is effective in reducing alopecia, particularly for non-anthracycline-based shorter regimens. Penguin was well tolerated and viewed favorably by most patients.