Background: Chemotherapy-induced alopecia (CIA) is a distressing side effect of cancer therapy. The trial aimed to assess feasibility and effectiveness of scalp-cooling system DigniCap® to prevent CIA in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). Methods: Hair loss (HL) was evaluated by patient self-assessment and by the physician according to the Dean's scale at baseline and after each cycle of CT. The primary efficacy endpoint was the patient self-assessment HL score evaluated at least 3 weeks after completing CT. A Dean's scale score of 0-2 (i.e. HL ≤50%) was considered a success. Results: From July 2014 to November 2016, 139 consecutive breast cancer patients were enrolled and received at least one treatment with scalp cooling. Fifty-six out of 131 evaluated patients successfully prevented HL (43%, 95% CI: 34-51%). Twenty-four patients (32%) discontinued the scalp cooling because of alopecia or scalp-cooling related AE, three patients had missing information on CIA, and 48 patients (64%) had a HL greater than 50% after CT. No serious AEs were reported. Conclusions: DigniCap® System resulted as a promising medical device to be safely integrated in supportive care of early breast cancer patients. Longer follow-up is needed to assess long-term safety and feasibility.
Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines / E. Munzone, V. Bagnardi, G. Campennì, K. Mazzocco, E. Pagan, A. Tramacere, M. Masiero, M. Iorfida, M. Mazza, E. Montagna, G. Cancello, N. Bianco, A. Palazzo, A. Cardillo, S. Dellapasqua, C. Sangalli, G. Pettini, G. Pravettoni, M. Colleoni, P. Veronesi. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - 121:4(2019 Aug), pp. 325-331.
|Titolo:||Preventing chemotherapy-induced alopecia : a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines|
|Settore Scientifico Disciplinare:||Settore MED/18 - Chirurgia Generale|
|Data di pubblicazione:||ago-2019|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1038/s41416-019-0520-8|
|Appare nelle tipologie:||01 - Articolo su periodico|
File in questo prodotto:
|BJC_Preventing chemotherapy-induce alopecia 2019.pdf||Publisher's version/PDF||Open Access Visualizza/Apri|