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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
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)....
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738323/ https://www.ncbi.nlm.nih.gov/pubmed/31303642 http://dx.doi.org/10.1038/s41416-019-0520-8 |
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author | Munzone, Elisabetta Bagnardi, Vincenzo Campennì, Giuseppe Mazzocco, Ketti Pagan, Eleonora Tramacere, Andrea Masiero, Marianna Iorfida, Monica Mazza, Manuelita Montagna, Emilia Cancello, Giuseppe Bianco, Nadia Palazzo, Antonella Cardillo, Anna Dellapasqua, Silvia Sangalli, Claudia Pettini, Greta Pravettoni, Gabriella Colleoni, Marco Veronesi, Paolo |
author_facet | Munzone, Elisabetta Bagnardi, Vincenzo Campennì, Giuseppe Mazzocco, Ketti Pagan, Eleonora Tramacere, Andrea Masiero, Marianna Iorfida, Monica Mazza, Manuelita Montagna, Emilia Cancello, Giuseppe Bianco, Nadia Palazzo, Antonella Cardillo, Anna Dellapasqua, Silvia Sangalli, Claudia Pettini, Greta Pravettoni, Gabriella Colleoni, Marco Veronesi, Paolo |
author_sort | Munzone, Elisabetta |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6738323 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-67383232020-07-15 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 Munzone, Elisabetta Bagnardi, Vincenzo Campennì, Giuseppe Mazzocco, Ketti Pagan, Eleonora Tramacere, Andrea Masiero, Marianna Iorfida, Monica Mazza, Manuelita Montagna, Emilia Cancello, Giuseppe Bianco, Nadia Palazzo, Antonella Cardillo, Anna Dellapasqua, Silvia Sangalli, Claudia Pettini, Greta Pravettoni, Gabriella Colleoni, Marco Veronesi, Paolo Br J Cancer Article 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. Nature Publishing Group UK 2019-07-15 2019-08-13 /pmc/articles/PMC6738323/ /pubmed/31303642 http://dx.doi.org/10.1038/s41416-019-0520-8 Text en © The Author(s), under exclusive licence to Cancer Research UK 2019 https://creativecommons.org/licenses/by/4.0/This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons Attribution 4.0 International (CC BY 4.0). |
spellingShingle | Article Munzone, Elisabetta Bagnardi, Vincenzo Campennì, Giuseppe Mazzocco, Ketti Pagan, Eleonora Tramacere, Andrea Masiero, Marianna Iorfida, Monica Mazza, Manuelita Montagna, Emilia Cancello, Giuseppe Bianco, Nadia Palazzo, Antonella Cardillo, Anna Dellapasqua, Silvia Sangalli, Claudia Pettini, Greta Pravettoni, Gabriella Colleoni, Marco Veronesi, Paolo 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738323/ https://www.ncbi.nlm.nih.gov/pubmed/31303642 http://dx.doi.org/10.1038/s41416-019-0520-8 |
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