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Background: The DigniCap System is an effective scalp cooling device for the prevention of chemotherapy‐induced alopecia in early breast cancer patients. Aim: This prospective study was designed to confirm the efficacy and tolerability of the device, to explore potential factors associated with its efficacy and to collect data on patient perceptions and satisfaction. Methods: Between January 2016 and June 2018, 163 early breast cancer patients eligible for adjuvant chemotherapy were enrolled. Hair loss was assessed using the Dean scale, where a score of 0–2 (hair loss ≤50%) was defined as successful. Results: Hair preservation was successful in 57% of patients in the overall series. The proportion was even higher (81%) in the patient subgroup treated with a paclitaxel and trastuzumab regimen. Side effects (feeling cold, headache, head heaviness, scalp and cervical pain) were mild to moderate and did not correlate with the rate of hair loss. Lifestyle, anthropometric factors and hair characteristics failed to be associated with device efficacy. Conclusions: The DigniCap System was well tolerated and found to be effective in preventing alopecia in early breast cancer patients. Our study failed to identify factors other than type of chemotherapy regimen associated with hair preservation. SUMMARY STATEMENT: What is already known about this topic? While the DigniCap System is known to be effective in preventing chemotherapy‐induced alopecia, nearly 50% of patients do not benefit from its use, and its side effects can be relevant.Identifying factors associated with the efficacy of scalp hypothermia is particularly important to avert the side effects of scalp cooling in patients unlikely to gain any advantage and to avoid unnecessarily prolonging chemotherapy chair occupation in patients at high risk of hair loss. What this paper adds? This single‐centre prospective study involving a relatively large series of breast cancer patients confirmed the efficacy and tolerability of the DigniCap.Our study failed to identify factors other than type of chemotherapy regimen significantly associated with hair preservation. The implications of this paper: Since a high success rate was observed in patients treated with paclitaxel and trastuzumab, use of the DigniCap may be recommended in breast cancer patients receiving this regimen.In other patients, the use of the device should be considered on an individual patient basis, balancing the efficacy rates and the longer duration of chemotherapy administration against the physical and psychological distress linked to hair loss.Oncology nurses can identify patients who are likely to develop early side effects and/or are unlikely to benefit from scalp hypothermia. [ABSTRACT FROM AUTHOR]