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)....
Gespeichert in:
| Veröffentlicht in: | British journal of cancer 2019-08, Vol.121 (4), p.325-331 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 331 |
|---|---|
| container_issue | 4 |
| container_start_page | 325 |
| container_title | British journal of cancer |
| container_volume | 121 |
| creator | 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 |
| 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. |
| doi_str_mv | 10.1038/s41416-019-0520-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6738323</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2272719454</sourcerecordid><originalsourceid>FETCH-LOGICAL-c470t-b7df13d9e42f0ccbc9684c263a624a8b1573675935c37b04cccba24ad1dec3d73</originalsourceid><addsrcrecordid>eNp1UcuKFDEUDaI47egHuJGA62heValyIcjgCwZ0oeuQSt3qzlCdlEm6h_oyf8_b9Djqwk3CzT0vcgh5LvgrwVX3umihRcu46BlvJGfdA7IRjZJMdNI8JBvOuWG8l_yCPCnlBseed-YxuVBCcdVquSE_v2Y4QqwhbqnfwT7VHWS3rCzE8eBhpG5OC_jg3lBHl5wKDjUcgfo5xODdTGsOeKZIkUlhmvDRr9TFkRY3QV1pmpBaELown9J8ciprqbCnIVJweV7pkMGVSr2LHjJdXA0YqaA0uIoZbkPdoWLdZZQ-GUN5Sh5Nbi7w7O6-JN8_vP929Yldf_n4-erdNfPa8MoGM05CjT1oOXHvB9-3nfayVa6V2nWDaIxqTdOrxiszcO0R43AzihG8Go26JG_Pusth2MPoMVd2s11y2Lu82uSC_XcTw85u09G2RnVKKhR4eSeQ048DlGpv0iFHzGylNNKIXjcaUeKM8vjFJcN07yC4PXVtz11b7NqeurYdcl78He2e8btcBMgzoOAqbiH_sf6_6i81YbrY</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2272719454</pqid></control><display><type>article</type><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><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><source>SpringerLink Journals - AutoHoldings</source><creator>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</creator><creatorcontrib>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</creatorcontrib><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.</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/s41416-019-0520-8</identifier><identifier>PMID: 31303642</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/1807/1812 ; 692/4028/67/1347 ; Adult ; Aged ; Alopecia ; Alopecia - chemically induced ; Alopecia - prevention & control ; Anthracycline ; Anthracyclines - adverse effects ; Baldness ; Biomedical and Life Sciences ; Biomedicine ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - psychology ; Cancer Research ; Cancer therapies ; Chemotherapy ; Clinical trials ; Cold Temperature ; Cooling ; Drug Resistance ; Epidemiology ; Feasibility studies ; Female ; Humans ; Medical devices ; Medical electronics ; Medical equipment ; Middle Aged ; Molecular Medicine ; Oncology ; Patients ; Prospective Studies ; Quality of Life ; Scalp ; Self evaluation ; Self-assessment ; Side effects</subject><ispartof>British journal of cancer, 2019-08, Vol.121 (4), p.325-331</ispartof><rights>The Author(s), under exclusive licence to Cancer Research UK 2019</rights><rights>Copyright Nature Publishing Group Aug 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-b7df13d9e42f0ccbc9684c263a624a8b1573675935c37b04cccba24ad1dec3d73</citedby><cites>FETCH-LOGICAL-c470t-b7df13d9e42f0ccbc9684c263a624a8b1573675935c37b04cccba24ad1dec3d73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738323/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6738323/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,41488,42557,51319,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31303642$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Munzone, Elisabetta</creatorcontrib><creatorcontrib>Bagnardi, Vincenzo</creatorcontrib><creatorcontrib>Campennì, Giuseppe</creatorcontrib><creatorcontrib>Mazzocco, Ketti</creatorcontrib><creatorcontrib>Pagan, Eleonora</creatorcontrib><creatorcontrib>Tramacere, Andrea</creatorcontrib><creatorcontrib>Masiero, Marianna</creatorcontrib><creatorcontrib>Iorfida, Monica</creatorcontrib><creatorcontrib>Mazza, Manuelita</creatorcontrib><creatorcontrib>Montagna, Emilia</creatorcontrib><creatorcontrib>Cancello, Giuseppe</creatorcontrib><creatorcontrib>Bianco, Nadia</creatorcontrib><creatorcontrib>Palazzo, Antonella</creatorcontrib><creatorcontrib>Cardillo, Anna</creatorcontrib><creatorcontrib>Dellapasqua, Silvia</creatorcontrib><creatorcontrib>Sangalli, Claudia</creatorcontrib><creatorcontrib>Pettini, Greta</creatorcontrib><creatorcontrib>Pravettoni, Gabriella</creatorcontrib><creatorcontrib>Colleoni, Marco</creatorcontrib><creatorcontrib>Veronesi, Paolo</creatorcontrib><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><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><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.</description><subject>692/1807/1812</subject><subject>692/4028/67/1347</subject><subject>Adult</subject><subject>Aged</subject><subject>Alopecia</subject><subject>Alopecia - chemically induced</subject><subject>Alopecia - prevention & control</subject><subject>Anthracycline</subject><subject>Anthracyclines - adverse effects</subject><subject>Baldness</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - psychology</subject><subject>Cancer Research</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Cold Temperature</subject><subject>Cooling</subject><subject>Drug Resistance</subject><subject>Epidemiology</subject><subject>Feasibility studies</subject><subject>Female</subject><subject>Humans</subject><subject>Medical devices</subject><subject>Medical electronics</subject><subject>Medical equipment</subject><subject>Middle Aged</subject><subject>Molecular Medicine</subject><subject>Oncology</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Scalp</subject><subject>Self evaluation</subject><subject>Self-assessment</subject><subject>Side effects</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1UcuKFDEUDaI47egHuJGA62heValyIcjgCwZ0oeuQSt3qzlCdlEm6h_oyf8_b9Djqwk3CzT0vcgh5LvgrwVX3umihRcu46BlvJGfdA7IRjZJMdNI8JBvOuWG8l_yCPCnlBseed-YxuVBCcdVquSE_v2Y4QqwhbqnfwT7VHWS3rCzE8eBhpG5OC_jg3lBHl5wKDjUcgfo5xODdTGsOeKZIkUlhmvDRr9TFkRY3QV1pmpBaELown9J8ciprqbCnIVJweV7pkMGVSr2LHjJdXA0YqaA0uIoZbkPdoWLdZZQ-GUN5Sh5Nbi7w7O6-JN8_vP929Yldf_n4-erdNfPa8MoGM05CjT1oOXHvB9-3nfayVa6V2nWDaIxqTdOrxiszcO0R43AzihG8Go26JG_Pusth2MPoMVd2s11y2Lu82uSC_XcTw85u09G2RnVKKhR4eSeQ048DlGpv0iFHzGylNNKIXjcaUeKM8vjFJcN07yC4PXVtz11b7NqeurYdcl78He2e8btcBMgzoOAqbiH_sf6_6i81YbrY</recordid><startdate>20190813</startdate><enddate>20190813</enddate><creator>Munzone, Elisabetta</creator><creator>Bagnardi, Vincenzo</creator><creator>Campennì, Giuseppe</creator><creator>Mazzocco, Ketti</creator><creator>Pagan, Eleonora</creator><creator>Tramacere, Andrea</creator><creator>Masiero, Marianna</creator><creator>Iorfida, Monica</creator><creator>Mazza, Manuelita</creator><creator>Montagna, Emilia</creator><creator>Cancello, Giuseppe</creator><creator>Bianco, Nadia</creator><creator>Palazzo, Antonella</creator><creator>Cardillo, Anna</creator><creator>Dellapasqua, Silvia</creator><creator>Sangalli, Claudia</creator><creator>Pettini, Greta</creator><creator>Pravettoni, Gabriella</creator><creator>Colleoni, Marco</creator><creator>Veronesi, Paolo</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20190813</creationdate><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><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></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-b7df13d9e42f0ccbc9684c263a624a8b1573675935c37b04cccba24ad1dec3d73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>692/1807/1812</topic><topic>692/4028/67/1347</topic><topic>Adult</topic><topic>Aged</topic><topic>Alopecia</topic><topic>Alopecia - chemically induced</topic><topic>Alopecia - prevention & control</topic><topic>Anthracycline</topic><topic>Anthracyclines - adverse effects</topic><topic>Baldness</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - psychology</topic><topic>Cancer Research</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Cold Temperature</topic><topic>Cooling</topic><topic>Drug Resistance</topic><topic>Epidemiology</topic><topic>Feasibility studies</topic><topic>Female</topic><topic>Humans</topic><topic>Medical devices</topic><topic>Medical electronics</topic><topic>Medical equipment</topic><topic>Middle Aged</topic><topic>Molecular Medicine</topic><topic>Oncology</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Scalp</topic><topic>Self evaluation</topic><topic>Self-assessment</topic><topic>Side effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Munzone, Elisabetta</creatorcontrib><creatorcontrib>Bagnardi, Vincenzo</creatorcontrib><creatorcontrib>Campennì, Giuseppe</creatorcontrib><creatorcontrib>Mazzocco, Ketti</creatorcontrib><creatorcontrib>Pagan, Eleonora</creatorcontrib><creatorcontrib>Tramacere, Andrea</creatorcontrib><creatorcontrib>Masiero, Marianna</creatorcontrib><creatorcontrib>Iorfida, Monica</creatorcontrib><creatorcontrib>Mazza, Manuelita</creatorcontrib><creatorcontrib>Montagna, Emilia</creatorcontrib><creatorcontrib>Cancello, Giuseppe</creatorcontrib><creatorcontrib>Bianco, Nadia</creatorcontrib><creatorcontrib>Palazzo, Antonella</creatorcontrib><creatorcontrib>Cardillo, Anna</creatorcontrib><creatorcontrib>Dellapasqua, Silvia</creatorcontrib><creatorcontrib>Sangalli, Claudia</creatorcontrib><creatorcontrib>Pettini, Greta</creatorcontrib><creatorcontrib>Pravettoni, Gabriella</creatorcontrib><creatorcontrib>Colleoni, Marco</creatorcontrib><creatorcontrib>Veronesi, Paolo</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Munzone, Elisabetta</au><au>Bagnardi, Vincenzo</au><au>Campennì, Giuseppe</au><au>Mazzocco, Ketti</au><au>Pagan, Eleonora</au><au>Tramacere, Andrea</au><au>Masiero, Marianna</au><au>Iorfida, Monica</au><au>Mazza, Manuelita</au><au>Montagna, Emilia</au><au>Cancello, Giuseppe</au><au>Bianco, Nadia</au><au>Palazzo, Antonella</au><au>Cardillo, Anna</au><au>Dellapasqua, Silvia</au><au>Sangalli, Claudia</au><au>Pettini, Greta</au><au>Pravettoni, Gabriella</au><au>Colleoni, Marco</au><au>Veronesi, Paolo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>British journal of cancer</jtitle><stitle>Br J Cancer</stitle><addtitle>Br J Cancer</addtitle><date>2019-08-13</date><risdate>2019</risdate><volume>121</volume><issue>4</issue><spage>325</spage><epage>331</epage><pages>325-331</pages><issn>0007-0920</issn><eissn>1532-1827</eissn><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.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>31303642</pmid><doi>10.1038/s41416-019-0520-8</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0007-0920 |
| ispartof | British journal of cancer, 2019-08, Vol.121 (4), p.325-331 |
| issn | 0007-0920 1532-1827 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6738323 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central; SpringerLink Journals - AutoHoldings |
| subjects | 692/1807/1812 692/4028/67/1347 Adult Aged Alopecia Alopecia - chemically induced Alopecia - prevention & control Anthracycline Anthracyclines - adverse effects Baldness Biomedical and Life Sciences Biomedicine Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - psychology Cancer Research Cancer therapies Chemotherapy Clinical trials Cold Temperature Cooling Drug Resistance Epidemiology Feasibility studies Female Humans Medical devices Medical electronics Medical equipment Middle Aged Molecular Medicine Oncology Patients Prospective Studies Quality of Life Scalp Self evaluation Self-assessment Side effects |
| 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 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-07T03%3A41%3A08IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Preventing%20chemotherapy-induced%20alopecia:%20a%20prospective%20clinical%20trial%20on%20the%20efficacy%20and%20safety%20of%20a%20scalp-cooling%20system%20in%20early%20breast%20cancer%20patients%20treated%20with%20anthracyclines&rft.jtitle=British%20journal%20of%20cancer&rft.au=Munzone,%20Elisabetta&rft.date=2019-08-13&rft.volume=121&rft.issue=4&rft.spage=325&rft.epage=331&rft.pages=325-331&rft.issn=0007-0920&rft.eissn=1532-1827&rft_id=info:doi/10.1038/s41416-019-0520-8&rft_dat=%3Cproquest_pubme%3E2272719454%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2272719454&rft_id=info:pmid/31303642&rfr_iscdi=true |