Effectiveness of the DigniCap® Scalp Cooling System for the Prevention of Chemotherapy-Induced Alopecia: An Observational Study in a Uruguayan Cohort.

BACKGROUND: Chemotherapy-induced alopecia is one of the most frequent and distressing adverse effects of systemic treatment in patients with breast cancer, with a relevant negative impact on body image and quality of life. Scalp cooling represents the most promising available preventive strategy; however, evidence from middle-income countries and real-world clinical practice remains limited. The objective of this study was to evaluate the effectiveness and tolerability of the DigniCap® scalp cooling system (Dignitana AB, Lund, Sweden) for preventing chemotherapy-induced alopecia (CIA), as well as its impact on quality of life, among Uruguayan patients with early breast cancer (EBC) receiving adjuvant or neoadjuvant treatment. METHODS: An observational, analytical, longitudinal, ambispective, single-arm study was conducted, including patients with early breast cancer who used the DigniCap® system between April 2022 and August 2025. The degree of alopecia was assessed using the Dean scale, with success defined as hair loss ≤50%. Quality of life, symptom perception, and psychosocial impact were evaluated using validated questionnaires and scales, including the European Organisation for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). RESULTS: A total of 137 patients were included, with a median age of 48 years. Treatment with DigniCap® was completed by 89.1% of patients. Alopecia assessment using the Dean scale was feasible in 95.6% of the cohort (n=131); of these evaluable patients, 86.3% (n=113) achieved alopecia ≤50% (treatment success). No statistically significant differences were observed according to age, institution of care, or chemotherapy regimen. The most frequent adverse events were headache, pruritus, and local discomfort, generally mild to moderate in intensity and well tolerated. A positive perception of body image and a favorable impact on quality of life were observed. CONCLUSIONS: The DigniCap® scalp cooling system demonstrated high effectiveness and good tolerability in preventing chemotherapy-induced alopecia in this cohort. The observed success rate was within the upper range reported in international series, although cross-study comparisons should be interpreted cautiously given differences in patient populations, chemotherapy regimens, and study methodology. These findings support the implementation of DigniCap® as a safe and well-tolerated strategy for the prevention of chemotherapy-induced alopecia, with a potential favorable impact on patients' body image during oncologic treatment.