COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer
PURPOSE: Chemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been la...
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| Hauptverfasser: | , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2019
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| In: |
Breast cancer research and treatment
Year: 2019, Jahrgang: 173, Heft: 1, Pages: 135-143 |
| ISSN: | 1573-7217 |
| Online-Zugang: |
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| Verfasserangaben: | Katharina Smetanay, Philippe Junio, Manuel Feißt, Julia Seitz, Jessica Cecile Hassel, Luisa Mayer, Lina Maria Matthies, Arina Schumann, André Hennigs, Jörg Heil, Christof Sohn, Dirk Jaeger, Andreas Schneeweiss, Frederik Marmé |
MARC
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| 245 | 1 | 0 | |a COOLHAIR |b a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer |c Katharina Smetanay, Philippe Junio, Manuel Feißt, Julia Seitz, Jessica Cecile Hassel, Luisa Mayer, Lina Maria Matthies, Arina Schumann, André Hennigs, Jörg Heil, Christof Sohn, Dirk Jaeger, Andreas Schneeweiss, Frederik Marmé |
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| 520 | |a PURPOSE: Chemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been lacking. - METHODS: Patients undergoing (neo)adjuvant chemotherapy for early breast cancer (EBC) were randomized to scalp cooling (CAP) or observation (NoCAP). All patients received 18-24 weeks of anthracycline- and/or taxane-based chemotherapy. The primary endpoint was patient-reported rate of alopecia according to a modified version of the Dean Scale. Hair preservation was defined as hair loss ≤ grade 2 (≤ 50%). Secondary endpoints were rate of alopecia determined by medical staff, rate of wig/scarf use, tolerability as well as quality of life (QoL). - RESULTS: Seventy-nine patients were randomized. Hair preservation was observed in 39.3% of patients in the CAP arm versus 0% in the NoCAP arm (p < 0.001). Wig/scarf use was significantly less frequent in the CAP group (40.7% vs 95.5% outside home before cycle 3, p < 0.001). The drop-out rate was 31.7% and 34.2% in the CAP and NoCAP arm, respectively. Main reasons for drop-out were hair loss, adverse events (CAP), and randomization into control arm. We observed no differences in efficacy between anthracycline-based and non-anthracycline-based regimens. QoL did not differ between the study arms. - CONCLUSIONS: This trial adds to the evidence that scalp cooling effectively prevents CIA in a meaningful number of patients. This option should be made available for patients undergoing (neo)adjuvant chemotherapy for EBC. | ||
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Aged, 80 and over | |
| 650 | 4 | |a Alopecia | |
| 650 | 4 | |a Antineoplastic Combined Chemotherapy Protocols | |
| 650 | 4 | |a Breast cancer | |
| 650 | 4 | |a Breast Neoplasms | |
| 650 | 4 | |a Chemotherapy | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Hair | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Hypothermia, Induced | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Neoadjuvant Therapy | |
| 650 | 4 | |a Prospective Studies | |
| 650 | 4 | |a Quality of life | |
| 650 | 4 | |a Quality of Life | |
| 650 | 4 | |a Scalp | |
| 650 | 4 | |a Scalp cooling | |
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