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

Elisabetta Munzone, Vincenzo Bagnardi, Giuseppe Campennì, Ketti Mazzocco, Eleonora Pagan, Andrea Tramacere, Marianna Masiero, Monica Iorfida, Manuelita Mazza, Emilia Montagna, Giuseppe Cancello, Nadia Bianco, Antonella Palazzo, Anna Cardillo, Silvia Dellapasqua, Claudia Sangalli, Greta Pettini, Gabriella Pravettoni, Marco Colleoni, Paolo Veronesi, Elisabetta Munzone, Vincenzo Bagnardi, Giuseppe Campennì, Ketti Mazzocco, Eleonora Pagan, Andrea Tramacere, Marianna Masiero, Monica Iorfida, Manuelita Mazza, Emilia Montagna, Giuseppe Cancello, Nadia Bianco, Antonella Palazzo, Anna Cardillo, Silvia Dellapasqua, Claudia Sangalli, Greta Pettini, Gabriella Pravettoni, Marco Colleoni, Paolo Veronesi

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.

Conflict of interest statement

E.M. has received honorarium as consultant/advisory role from PierreFabre, Genomic Health. M.C. has received honorarium as consultant/advisory role from Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, Celldex, AstraZeneca, Novartis. E.M. has received honorarium as consultant/advisory role from PierreFabre. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of patients in the trial

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Source: PubMed

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