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Abstract Introduction: Chemotherapy-induced alopecia (CIA) is a distressing side effect of breast cancer (BC) treatment. Scalp cooling (SC) devices have shown promise in reducing the severity of CIA. However, the impact of reducing alopecia occurrence on the quality of life of Brazilian patients remains unclear. Objectives: This study aimed to assess the effectiveness of the Capelli System, a new SC device, in reducing CIA. Methods: This was a single-center, controlled, randomized phase 2 clinical trial involving women with TNM stage I to III BC undergoing neoadjuvant or adjuvant doxorubicin-based chemotherapy (AC regimen: doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m², i.v., q21 days), with or without a taxane (paclitaxel or docetaxel). Participants were randomized in a 1:3 ratio into the scalp cooling (n = 33) or control (n = 12) groups. All participants were advised to cut their hair short and avoid heat-inducing tools or processes throughout chemotherapy, using cold or lukewarm water and wide-toothed combs for hair washing. The primary efficacy endpoint was grade 2 alopecia (50% hair loss or hair shaving due to alopecia) after 4 cycles of AC. Secondary endpoints included measures of hair loss distress (BRHL) and body image (BRBI) from the EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23), as well as symptoms of anxiety and depression from the Hospital Anxiety and Depression Scale (HADS). Fitzpatrick phototype and hair type were assessed. Statistical analyses utilized generalized linear models and Fisher's Exact test (p-value 0.05). Results: Patients were enrolled from October 11, 2019, to January 17, 2022. Out of the 45 patients included, 8 were excluded: 2 due to intolerance, 1 with alopecia associated with COVID-19, and 5 who withdrew consent (2 with grade 2 headache, 3 without justification). The median age was 44.6 (min-max: 23-63) years, with 18 (40%) and 27 (60%) receiving adjuvant and neoadjuvant chemotherapy, respectively. Grade 2 alopecia or hair shaving occurred in 52% of scalp cooling patients and 100% of controls (p = 0.003), demonstrating a significant 48% reduction in alopecia. There were no significant differences in HADS-A, HADS-D, BRHL, or BRBI scores between the two groups. Alopecia occurrence did not show significant associations with skin or hair types. No serious adverse events related to the scalp cooling device were reported. Conclusions: SC with the Capelli System significantly reduced CIA by half. Some patients experienced discomfort or headaches and discontinued device use. Further research is needed to understand why reduced alopecia rates do not correlate with improvements in body image or reduced hair loss distress. Citation Format: Carlos Paiva, Fabiola Dias, Angelo Matthes, Bianca Paiva, Cristiano Souza, Domício Lacerda, Augusto Antoniazzi, Maria Fernanda Machado, Matheus Godinho, Crislaine de Lima, Cristiane Cárcano, Marina Zorzetto. Scalp Cooling with the Capelli System to Reduce Doxorubicin-induced Alopecia in Patients with Localized Breast Cancer: A Phase 2 Randomized Controlled Trial abstract. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-05.
Paiva et al. (Thu,) studied this question.