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.

Munzone, E., Bagnardi, V., Campennì, G., Mazzocco, K., Pagan, E., Tramacere, A., et al. (2019). 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. BRITISH JOURNAL OF CANCER, 121(4), 325-331 [10.1038/s41416-019-0520-8].

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

Bagnardi, Vincenzo;Pagan, Eleonora;
2019

Abstract

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.
Articolo in rivista - Articolo scientifico
Chemotherapy-induced alopecia, breast cancer, scalp cooling cap system, DigniCap®
English
15-lug-2019
2019
121
4
325
331
open
Munzone, E., Bagnardi, V., Campennì, G., Mazzocco, K., Pagan, E., Tramacere, A., et al. (2019). 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. BRITISH JOURNAL OF CANCER, 121(4), 325-331 [10.1038/s41416-019-0520-8].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/239382
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