Efficacy and tolerability of scalp cooling in preventing alopecia during (neo)adjuvant chemotherapy for breast cancer.

Background: Modern chemotherapies substantially improve survival rates in patients with breast cancer; however, its associated adverse effects can markedly diminish quality of life. Chemotherapy-induced alopecia is among the most common and distressing side effects. This study aimed to evaluate the efficacy and tolerability of the PAXMAN® scalp cooling system in preventing chemotherapy-induced alopecia among women with breast cancer receiving (neo)adjuvant chemotherapy. Methods: We conducted a prospective clinical study enrolling patients with early-stage breast cancer who received Orbis PAXMAN® scalp cooling during (neo)adjuvant chemotherapy. The extent of alopecia was assessed at the discontinuation of scalp cooling using the CTCAE v5 scale. Patient characteristics-age, menopausal status, hair length, color, quality, and prior treatments (e.g., dyeing, perming), as well as skin type, eye color, comorbidities, alcohol consumption, smoking, and chemotherapy regimen-were recorded. Associations between patient-related factors and the severity of alopecia were analyzed. Patients evaluated pain, cold sensation, and overall tolerability of the cooling process using a visual analogue scale. Results: Fifty female patients were enrolled. The mean age was 52 years (range 31-77); 27 patients were premenopausal and 23 were postmenopausal. Forty-two patients received an anthracycline-based regimen, while eight received anthracycline-free chemotherapy. Treatment discontinuation occurred in 31 cases due to severe alopecia and in one case due to intolerable pain. Grade 1 alopecia was observed in 18 patients (36%). The cooling cap combined with a 60-min post-cooling period demonstrated a promising success rate among patients receiving anthracycline-free regimens (69%), whereas efficacy was less favorable in anthracycline-based protocols (37.5%). Among the examined patient characteristics, only the presence of comorbidities showed a significant association with the severity of alopecia (p = 0.028). Most patients found the scalp cooling system comfortable; the mean scalp pain score was 2.17 and the mean cold sensation score was 3.9 on the visual analogue scale. Conclusion: The Orbis PAXMAN® scalp cooling system is an effective and well-tolerated method for preventing chemotherapy-induced alopecia, particularly in patients receiving anthracycline-free regimens. The presence of comorbidities significantly increased the risk of severe alopecia. While this study confirms that the efficacy of scalp cooling is strongly influenced by the chemotherapy regimen, further research is warranted to optimize patient selection and improve outcomes, especially for those undergoing anthracycline-based therapies.