TY - JOUR
T1 - Preventing chemotherapy-induced alopecia
T2 - a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines
AU - Munzone, Elisabetta
AU - Bagnardi, Vincenzo
AU - Campennì, Giuseppe
AU - Mazzocco, Ketti
AU - Pagan, Eleonora
AU - Tramacere, Andrea
AU - Masiero, Marianna
AU - Iorfida, Monica
AU - Mazza, Manuelita
AU - Montagna, Emilia
AU - Cancello, Giuseppe
AU - Bianco, Nadia
AU - Palazzo, Antonella
AU - Cardillo, Anna
AU - Dellapasqua, Silvia
AU - Sangalli, Claudia
AU - Pettini, Greta
AU - Pravettoni, Gabriella
AU - Colleoni, Marco
AU - Veronesi, Paolo
PY - 2019/8/13
Y1 - 2019/8/13
N2 - 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. Clinical trial registration number: NCT03712696.
AB - 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. Clinical trial registration number: NCT03712696.
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U2 - 10.1038/s41416-019-0520-8
DO - 10.1038/s41416-019-0520-8
M3 - Article
C2 - 31303642
AN - SCOPUS:85069036438
VL - 121
SP - 325
EP - 331
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 4
ER -